CONSENT IN ENGLISH

INFORMED CONSENT FOR NEPHRECTOMY (KIDNEY REMOVAL SURGERY)

Patient Name: ____________________________________________________
Date of Birth: _____________________ Hospital/NIC Number: _____________________

1. Confirmation of Discussion

I, the undersigned, confirm that Dr. ____________________________________________________ has provided me with comprehensive information regarding my diagnosis of a Nonfunctioning Kidneyand the available treatment options. The doctor has explained the nature of my condition, the proposed procedure, its intended benefits, and the material risks involved. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction.

2. Understanding My Condition

I understand that one of my kidneys (right/left) is no longer functioning adequately. A nonfunctioning kidney can lead to several problems, including:

• Chronic Pain or Discomfort in the flank or abdomen.

• High Blood Pressure (Hypertension) due to hormonal signals from the diseased kidney.

• Recurrent Infections that can spread to the bloodstream.

• Risk of Pyonephrosis (collection of pus in the kidney).

• Rarely, a long-term risk of malignancy (cancer) in a nonfunctioning kidney.

Removing the nonfunctioning kidney (Nephrectomy) is recommended to alleviate these symptoms and prevent future complications.

3. Procedure Description

I voluntarily agree to undergo Nephrectomy (Kidney Removal Surgery) , performed by the team of Dr. ____________________________________________________, to remove my RIGHT / LEFTnonfunctioning kidney. I understand the following about the procedure:

3.1 Pre-Operative Preparation

• I will undergo a Pre-Anesthetic Checkup (PAC) to ensure I am fit for surgery and anesthesia. This involves blood tests, heart tracing (ECG), and chest X-ray as needed.

• I understand that the surgery will be performed by a team consisting of my urologist, an anesthesiologist, and other specialists as required.

3.2 Anesthesia

• The surgery will be performed under General Anesthesia, meaning I will be completely asleep and pain-free during the procedure. A breathing tube may be inserted to help me breathe (ventilator support during surgery).

3.3 Surgical Approaches
I understand that the surgeon will use one of the following methods to remove my kidney, and I consent to either approach as deemed appropriate by the surgical team:

• Open Nephrectomy: The surgeon will make a single incision (cut) in my flank (side) or abdomen, typically 10-20 cm long, through which the kidney is removed.

• Laparoscopic Nephrectomy (Minimally Invasive): The surgeon will make 3 to 4 small incisions (usually 0.5-1.5 cm each) in my abdomen.

  • Carbon dioxide gas will be gently pumped into my abdomen to create space for the surgeon to work.

  • A tiny camera (laparoscope) and long, thin instruments are inserted through these small incisions to perform the surgery.

  • The kidney is placed in a bag and removed through one of the small incisions, which may be slightly enlarged for this purpose.

• Robotic-Assisted Nephrectomy: This is a form of laparoscopic surgery where the surgeon controls robotic arms from a console for enhanced precision.

3.4 Conversion from Laparoscopic to Open Surgery

• I understand that during a laparoscopic procedure, unexpected findings or complications may arise (such as bleeding or dense scar tissue). In such cases, the surgeon may need to convert to an open procedure by making a larger incision to safely complete the operation. This is not a complication, but a sound surgical judgment to ensure my safety.

4. Post-Operative Care and Recovery

• Hospital Stay: After the surgery, I will be moved to a recovery room and then to a hospital ward. I will likely remain in the hospital for 3 to 7 days, depending on my recovery and the type of surgery performed.

• Pain Management: I will receive medications to manage post-operative pain.

• Activity: I will be encouraged to walk and move around soon after surgery to prevent blood clots, but I will need to avoid heavy lifting for several weeks.

• Follow-Up: After discharge, I must attend regular follow-up appointments with my specialist as scheduled to monitor my recovery and the function of my remaining kidney.

• Lifestyle: I understand that I will need to maintain a healthy lifestyle to protect my remaining single kidney, including staying well-hydrated and avoiding medications that can harm the kidneys (such as NSAIDs like ibuprofen/diclofenac) unless approved by my doctor.

5. Understanding of Risks and Potential Complications

I acknowledge that no surgery or medical procedure is without risk. I have been informed about the potential problems that could occur during or after the Nephrectomy procedure. These include, but are not limited to:

5.1 Anesthesia-Related Risks

• Potential reactions to anesthetic drugs, including allergies, significant drops or rises in blood pressure, or heart rate fluctuations.

• In rare circumstances (approximately 0.5% ), these issues can be life-threatening and may require the use of a breathing machine (ventilator) or other life-support measures.

5.2 Bleeding and Blood Transfusion

• Excessive bleeding during or after surgery (approximately 1% ) may require a blood transfusion.

• I understand that blood transfusions carry their own small risks, including allergic reactions, fever, and very rare risks of infection (approximately 5% for minor adverse effects).

• In rare cases, severe bleeding may require a return to the operating room (re-operation) to control it.

5.3 Specific Risks of Laparoscopic Surgery (if applicable)

• Gas Insufflation Effects: The carbon dioxide gas used to inflate my abdomen can sometimes cause temporary shoulder pain after surgery. Rarely, it can lead to pressure on the heart or lungs, causing fluctuations in blood pressure or heart rate during the procedure. The anesthesia team monitors this closely.

• Gas Embolism: A very rare but serious condition where gas enters the bloodstream.

• Conversion to Open Surgery: As mentioned in section 3.4, there is a 5% chance that the laparoscopic procedure may need to be converted to an open surgery due to bleeding, dense adhesions, or difficulty visualizing the anatomy.

5.4 Injury to Surrounding Organs and Structures
The kidney is located near several major organs and blood vessels. During surgery, there is a small risk of injuring these structures (approximately 1% ), which may require immediate repair or a separate re-operation:

• Major Blood Vessels: Such as the Inferior Vena Cava (the body’s main vein), Aorta, or Renal Vessels.

• Right-Sided Surgery: Risk of injury to the Liver, Duodenum (first part of the small intestine), and Pleura (lining of the lung).

• Left-Sided Surgery: Risk of injury to the Spleen, Pancreas, Colon (large intestine), and Pleura(lining of the lung).

• Nerve Injury: Nerves in the area may be affected, leading to numbness or weakness in the surrounding muscles.

5.5 Incomplete Surgery / Aborted Procedure

• In rare circumstances (approximately 0.5% ), due to unexpected findings (such as severe infection, dense scar tissue, or cancer spread), the surgeon may decide that it is safer to stop the procedure without removing the kidney.

5.6 Infection

• Wound Infection: The surgical incision(s) may become infected (approximately 4% ), requiring antibiotics or drainage.

• Urinary Tract Infection (UTI): A catheter is placed during surgery, which carries a risk of UTI.

• Sepsis (Blood Infection): A severe, body-wide infection that can be life-threatening (approximately 5% ). Sepsis requires immediate treatment with strong intravenous antibiotics and may necessitate a prolonged stay in the Intensive Care Unit (ICU).

5.7 Respiratory Complications

• Chest Infection (Pneumonia): Approximately 0.5% risk, especially in patients who smoke or have lung conditions.

• Pleural Injury: If the pleura (lung lining) is injured, air or fluid may collect around the lung (pneumothorax or pleural effusion), requiring a chest tube for drainage.

5.8 Blood Clots (Thromboembolism)

• Deep Vein Thrombosis (DVT): Blood clots can form in the leg veins (approximately 0.5% ) due to immobility during and after surgery.

• Pulmonary Embolism (PE): If a clot travels to the lungs, it can be life-threatening. Preventative measures (blood thinners, compression stockings, early mobilization) will be used to reduce this risk.

5.9 Chronic Pain and Wound Issues

• Painful Scar and Neuralgia: The surgical scar may remain painful, numb, or sensitive for a long time (approximately 10% ). This is due to nerve entrapment or injury during surgery.

• Incisional Hernia: The abdominal muscles may weaken at the incision site, allowing internal tissue to bulge through. This occurs in approximately 1-2% of cases and may require future surgery to repair.

5.10 Kidney Function and Renal Failure

• I understand that I will be left with one functioning kidney. My remaining kidney will typically enlarge and compensate (work harder) to filter my blood.

• There is a small risk (approximately 1% ) of Acute Kidney Injury (AKI) , where the remaining kidney is stressed and may temporarily not work well.

• In patients with pre-existing reduced function in the remaining kidney, there is a very small long-term risk of progressing to End Stage Renal Disease (ESRD) , which would require dialysis or a kidney transplant.

5.11 Mortality

• I understand that, as with any major surgery involving general anesthesia, there is a small risk of death. For a nephrectomy, this risk is approximately 0.003% to 0.5% depending on my overall health.

5.12 Other Potential Issues

6. Prognosis and Alternatives

I understand the risks of not having the surgery, which include:

• Persistent or worsening pain.

• Uncontrolled high blood pressure.

• Recurrent infections that could lead to sepsis.

• Rare risk of cancer developing in the nonfunctioning kidney.

I am aware that alternative treatments (such as conservative management with monitoring) have been discussed, but based on my condition, surgery is the recommended option.

7. Patient Acknowledgement and Agreement

• Understanding and Voluntarily Consent: I confirm that I have read (or have had read to me) the information above. I understand the nature of the Nephrectomy procedure, its intended benefits, and the material risks outlined. I believe I have sufficient information to make an informed decision, and I give my consent freely and voluntarily.

• No Guarantees: I understand that while the goal of the surgery is to remove the nonfunctioning kidney and improve my health, no guarantees or promises have been made to me about the results of this treatment. Medicine is not an exact science.

• Right to Change My Mind: I understand that I have the right to change my mind about having surgery at any time, even after signing this form. However, I confirm that I currently wish to proceed as discussed with my doctor.

• Acknowledgement of Responsibility: I understand that my cooperation and honesty regarding my medical history, medications, and lifestyle are essential. I agree to follow the doctor’s advice regarding post-operative care, follow-up appointments, and reporting any unusual symptoms (such as fever, heavy bleeding, or severe pain).

• Emergency Situations: I consent to the medical team taking any immediate and life-saving measures necessary during the surgery, as discussed with my doctors.

I have read this form (or it has been read and explained to me) and I understand its contents.

8. Signatures

Patient:

• Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

• Thumbprint (if applicable): __________________ Time: ______________

• Contact Address & Phone: ________________________________________________________________

Witness to Patient Signature (if required):

• Name: __________________________________ Designation: __________________________________

• Signature: __________________________________ Date: ______________

Interpreter (If patient does not understand the language used):
I have interpreted the information contained in this consent form to the patient to the best of my ability and in a language they understand. The patient has indicated that they understand the information and have given their consent freely.

• Name: __________________________________ Relationship: __________________________________

• Signature: __________________________________ Date: ______________

Physician Statement:
I have explained the nature, purpose, risks, benefits, and alternatives of this Nephrectomy procedure to the patient. I have answered their questions and believe they have a sufficient understanding to provide informed consent.

• Doctor’s Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

INFORMED CONSENT FOR RADICAL NEPHRECTOMY (KIDNEY CANCER SURGERY)

Patient Name: ____________________________________________________
Date of Birth: _____________________ Hospital/NIC Number: _____________________

1. Confirmation of Discussion

I, the undersigned, confirm that Dr. ____________________________________________________ has provided me with comprehensive information regarding my diagnosis of a Renal Mass / Kidney Tumor and the available treatment options. The doctor has explained the nature of my condition, the proposed procedure, its intended benefits, and the material risks involved. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction.

2. Understanding My Condition

I understand that a mass or tumor has been found in my kidney. Because of its size and appearance on imaging, it is highly likely to be kidney cancer (Renal Cell Carcinoma) . For this reason, a separate biopsy before surgery is often not required, except in special circumstances.

I understand that kidney cancer can sometimes spread (metastasize) to:

• The fat and tissue surrounding the kidney (perinephric fat).

• Nearby organs such as the liver, spleen, pancreas, or bowel.

• Major blood vessels, including the renal vein or the Inferior Vena Cava (IVC) , the body’s main vein that carries blood back to the heart. This is called a Tumor Thrombus.

• Lymph nodes in the area.

The goal of a Radical Nephrectomy is to remove the entire cancer along with the kidney and surrounding tissues to achieve the best chance of cure.

3. Procedure Description

I voluntarily agree to undergo Radical Nephrectomy , performed by the team of Dr. ____________________________________________________, to remove my RIGHT / LEFT kidney containing the tumor. I understand the following about the procedure:

3.1 Extent of Surgery

• Radical Nephrectomy involves removing the entire kidney along with the surrounding fat (Gerota’s fascia) and, in some cases, the adrenal gland which sits on top of the kidney.

• If the cancer has spread to nearby organs or lymph nodes, and if it is surgically possible to remove them safely, the surgeon may also remove:

  • Parts of the liver, spleen, pancreas, or bowel.

  • Enlarged lymph nodes (lymph node dissection).

• If the cancer has spread into the renal vein or the Inferior Vena Cava (Tumor Thrombus), the surgeon will need to open that blood vessel to remove the cancerous extension.

3.2 Pre-Operative Preparation

• I will undergo a Pre-Anesthetic Checkup (PAC) to ensure I am fit for surgery and anesthesia. This involves blood tests, heart tracing (ECG), and chest X-ray or other imaging as needed.

• The surgery will be performed by a team consisting of my urologist, an anesthesiologist, and other specialists (such as a cardiothoracic or vascular surgeon) as required.

3.3 Anesthesia

• The surgery will be performed under General Anesthesia, meaning I will be completely asleep and pain-free during the procedure. A breathing tube will be inserted to help me breathe (ventilator support during surgery).

3.4 Surgical Approaches
I understand that the surgeon will use one of the following methods, and I consent to either approach as deemed appropriate by the surgical team:

• Open Radical Nephrectomy: The surgeon will make a single incision (cut) in my flank (side) or abdomen, typically 15-25 cm long, through which the kidney and surrounding tissues are removed.

• Laparoscopic Radical Nephrectomy (Minimally Invasive): The surgeon will make 3 to 5 small incisions (usually 0.5-1.5 cm each) in my abdomen.

  • Carbon dioxide gas will be gently pumped into my abdomen to create space for the surgeon to work.

  • A tiny camera (laparoscope) and long, thin instruments are inserted through these small incisions to perform the surgery.

  • The kidney is placed in a bag and removed through one of the small incisions, which may be slightly enlarged for this purpose.

• Robotic-Assisted Radical Nephrectomy: This is a form of laparoscopic surgery where the surgeon controls robotic arms from a console for enhanced precision, especially useful for complex dissections.

3.5 Conversion from Laparoscopic to Open Surgery

• I understand that during a laparoscopic procedure, unexpected findings or complications (such as bleeding, dense scar tissue, or unexpected cancer spread) may arise. In such cases, the surgeon may need to convert to an open procedure by making a larger incision to safely complete the operation. This is not a complication, but a sound surgical judgment to ensure my safety.

4. Post-Operative Care and Recovery

• Hospital Stay: After the surgery, I will be moved to a recovery room and then to a hospital ward. I will likely remain in the hospital for 3 to 7 days, depending on my recovery and the complexity of the surgery.

• Pain Management: I will receive medications to manage post-operative pain.

• Drains and Tubes: I may have a surgical drain (to remove excess fluid) and a urinary catheter in place for a few days after surgery.

• Activity: I will be encouraged to walk and move around soon after surgery to prevent blood clots, but I will need to avoid heavy lifting for several weeks.

• Follow-Up: After discharge, I must attend regular follow-up appointments with my specialist as scheduled to monitor my recovery, the function of my remaining kidney, and to watch for any signs of cancer recurrence. This will involve periodic blood tests and scans (CT or ultrasound).

• Lifestyle: I understand that I will need to maintain a healthy lifestyle to protect my remaining single kidney, including staying well-hydrated and avoiding medications that can harm the kidneys (such as NSAIDs like ibuprofen/diclofenac) unless approved by my doctor.

5. Understanding of Risks and Potential Complications

I acknowledge that no surgery or medical procedure is without risk. I have been informed about the potential problems that could occur during or after the Radical Nephrectomy procedure. These include, but are not limited to:

5.1 Anesthesia-Related Risks

• Potential reactions to anesthetic drugs, including allergies, significant drops or rises in blood pressure, or heart rate fluctuations.

• In rare circumstances (approximately 0.5% ), these issues can be life-threatening and may require the use of a breathing machine (ventilator) or other life-support measures.

5.2 Bleeding and Blood Transfusion

• Excessive bleeding during or after surgery (approximately 1-5% ) may require a blood transfusion.

• I understand that blood transfusions carry their own small risks, including allergic reactions, fever, and very rare risks of infection (approximately 5% for minor adverse effects).

• In cases of severe bleeding, a return to the operating room (re-operation) may be needed to control it.

5.3 Specific Risks of Laparoscopic/Robotic Surgery

• Gas Insufflation Effects: The carbon dioxide gas used to inflate my abdomen can sometimes cause temporary shoulder pain after surgery. Rarely, it can lead to pressure on the heart or lungs, causing fluctuations in blood pressure or heart rate during the procedure (approximately 5% risk of significant hemodynamic changes). The anesthesia team monitors this closely.

• Gas Embolism: A very rare but serious condition where gas enters the bloodstream.

• Conversion to Open Surgery: As mentioned in section 3.5, there is a 5% chance that the laparoscopic procedure may need to be converted to an open surgery.

5.4 Injury to Surrounding Organs and Structures
The kidney is located near several major organs and blood vessels. During surgery, there is a risk of injuring these structures (approximately 1-2% ), which may require immediate repair or a separate re-operation:

• Right-Sided Surgery: Risk of injury to the Liver, Duodenum (first part of the small intestine), Inferior Vena Cava (IVC) , and Pleura (lining of the lung).

• Left-Sided Surgery: Risk of injury to the Spleen (which may require splenectomy – removal of the spleen), Pancreas (which could cause pancreatitis or a pancreatic leak/fistula), Colon (large intestine), and Pleura.

• Major Blood Vessels: The Aorta, Renal Artery and Vein, and Inferior Vena Cava are at risk. Injury to these vessels can cause life-threatening bleeding.

5.5 Involvement of Adjacent Organs (Multivisceral Resection)

• If the cancer has directly spread into nearby organs, the surgeon may need to remove a portion of that organ along with the kidney to achieve complete cancer removal (approximately 5% ). This may involve:

  • Partial liver resection.

  • Partial pancreas resection.

  • Spleen removal (splenectomy).

  • Bowel resection (removing a segment of the small or large intestine).

5.6 Bowel Injury and Stoma Formation (Ileostomy/Colostomy)

• If the intestine (bowel) is injured during surgery, or if the cancer has spread to the bowel and it must be removed, the surgeon will repair the bowel.

• In some cases, after removing a segment of bowel, it may not be safe to reconnect the ends immediately. This may require a temporary or permanent stoma (opening on the abdomen) called an Ileostomy or Colostomy, where stool drains into a bag on the outside of the body (approximately 1-5% risk depending on the extent of bowel involvement).

5.7 Tumor Thrombus (Cancer in the Vein)

• If the cancer has spread into the renal vein or the Inferior Vena Cava (tumor thrombus) , a more complex surgery is required (approximately 1-5% of cases).

• The surgeon must open the blood vessel to remove the cancer. This may require clamping major veins, which can affect blood flow to the heart.

• If the tumor thrombus extends all the way to the heart (right atrium), a specialized heart-lung machine called Cardiopulmonary Bypass may be needed, and a cardiac surgeon will assist. This carries additional risks, including heart attack, stroke, and bleeding disorders.

5.8 Incomplete Resection / Aborted Procedure

• In some cases (approximately 1% ), after the surgery has begun, the surgeon may find that the cancer is more advanced than expected. This could include:

  • Widespread cancer throughout the abdomen (peritoneal carcinomatosis).

  • Cancer fixed to major structures that cannot be safely removed.

• In these situations, the surgeon may decide that it is safer to stop the procedure without removing the kidney (aborted or incomplete resection). A biopsy may be taken, and alternative treatments (systemic therapy) will be discussed.

5.9 Infection

• Wound Infection: The surgical incision(s) may become infected (approximately 4% ), requiring antibiotics or drainage.

• Urinary Tract Infection (UTI): A catheter is placed during surgery, which carries a risk of UTI.

• Sepsis (Blood Infection): A severe, body-wide infection that can be life-threatening (approximately 5% ). Sepsis requires immediate treatment with strong intravenous antibiotics and may necessitate a prolonged stay in the Intensive Care Unit (ICU).

5.10 Respiratory Complications

• Chest Infection (Pneumonia): Approximately 0.5% risk, especially in patients who smoke or have lung conditions.

• Pleural Injury: If the pleura (lung lining) is injured, air or fluid may collect around the lung (pneumothorax or pleural effusion), requiring a chest tube for drainage.

5.11 Blood Clots (Thromboembolism)

• Deep Vein Thrombosis (DVT): Blood clots can form in the leg veins (approximately 0.5% ) due to immobility during and after surgery.

• Pulmonary Embolism (PE): If a clot travels to the lungs, it can be life-threatening. Preventative measures (blood thinners, compression stockings, early mobilization) will be used to reduce this risk.

5.12 Chronic Pain and Wound Issues

• Painful Scar and Neuralgia: The surgical scar may remain painful, numb, or sensitive for a long time (approximately 10% ). This is due to nerve entrapment or injury during surgery.

• Incisional Hernia: The abdominal muscles may weaken at the incision site, allowing internal tissue to bulge through. This occurs in approximately 1-2% of cases and may require future surgery to repair.

5.13 Kidney Function and Renal Failure

• I understand that I will be left with one functioning kidney. My remaining kidney will typically enlarge and compensate (work harder) to filter my blood.

• There is a risk of Acute Kidney Injury (AKI) after surgery (approximately 1-5% ), where the remaining kidney is stressed and may temporarily not work well. This may require temporary dialysis in rare cases.

• In patients with pre-existing reduced function in the remaining kidney, there is a long-term risk of progressing to End Stage Renal Disease (ESRD) , which would require permanent dialysis or a kidney transplant.

5.14 Cancer Recurrence

• Despite complete removal of the kidney and tumor, kidney cancer can recur (come back) in the body (approximately 10-20% over time, depending on the stage and grade of the original tumor).

• Recurrence can happen in the remaining kidney, in the surgical bed, or in distant organs (lungs, bones, liver, brain).

• If cancer recurs, further treatment may be needed, including targeted therapy, immunotherapy, or chemotherapy .

5.15 Mortality

• I understand that, as with any major surgery involving general anesthesia, there is a risk of death. For a Radical Nephrectomy, this risk is approximately 0.5% , depending on my overall health and the complexity of the surgery.

5.16 Other Potential Issues

6. Prognosis and Alternatives

I understand the risks of not having the surgery, which include:

• Growth and spread of the cancer (metastasis).

• Development of symptoms such as pain, bleeding, or weight loss.

• Potential for the cancer to become inoperable.

I am aware that alternative treatments have been discussed, which may include:

• Active Surveillance: Monitoring the tumor with regular scans (for small, slow-growing tumors in elderly or frail patients).

• Partial Nephrectomy (Nephron-Sparing Surgery): Removing only the tumor and leaving the rest of the kidney (if the tumor size and location allow).

• Thermal Ablation: Freezing or burning the tumor (for small tumors).

• Systemic Therapy: Targeted therapy or immunotherapy for advanced cancer.

Based on my condition, Radical Nephrectomy is the recommended option.

7. Patient Acknowledgement and Agreement

• Understanding and Voluntarily Consent: I confirm that I have read (or have had read to me) the information above. I understand the nature of the Radical Nephrectomy procedure, its intended benefits, and the material risks outlined. I believe I have sufficient information to make an informed decision, and I give my consent freely and voluntarily.

• No Guarantees: I understand that while the goal of the surgery is to remove all cancer and achieve cure, no guarantees or promises have been made to me about the results of this treatment. Medicine is not an exact science.

• Right to Change My Mind: I understand that I have the right to change my mind about having surgery at any time, even after signing this form. However, I confirm that I currently wish to proceed as discussed with my doctor.

• Acknowledgement of Responsibility: I understand that my cooperation and honesty regarding my medical history, medications, and lifestyle are essential. I agree to follow the doctor’s advice regarding post-operative care, follow-up appointments, and reporting any unusual symptoms.

• Emergency Situations: I consent to the medical team taking any immediate and life-saving measures necessary during the surgery, as discussed with my doctors. I am prepared for additional treatments (such as blood transfusion, stoma formation, or intensive care) in case of any complications.

I have read this form (or it has been read and explained to me) and I understand its contents.

8. Signatures

Patient:

• Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

• Thumbprint (if applicable): __________________ Time: ______________

• Contact Address & Phone: ________________________________________________________________

Witness to Patient Signature (if required):

• Name: __________________________________ Designation: __________________________________

• Signature: __________________________________ Date: ______________

Interpreter (If patient does not understand the language used):
I have interpreted the information contained in this consent form to the patient to the best of my ability and in a language they understand. The patient has indicated that they understand the information and have given their consent freely.

• Name: __________________________________ Relationship: __________________________________

• Signature: __________________________________ Date: ______________

Physician Statement:
I have explained the nature, purpose, risks, benefits, and alternatives of this Radical Nephrectomy procedure to the patient. I have answered their questions and believe they have a sufficient understanding to provide informed consent.

• Doctor’s Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

INFORMED CONSENT FOR RADICAL PROSTATECTOMY (PROSTATE CANCER SURGERY)

Patient Name: ____________________________________________________
Date of Birth: _____________________ Hospital/NIC Number: _____________________

1. Confirmation of Discussion

I, the undersigned, confirm that Dr. ____________________________________________________ has provided me with comprehensive information regarding my diagnosis of Prostate Cancer and the available treatment options. The doctor has explained the nature of my condition, the proposed procedure, its intended benefits, and the material risks involved. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction.

2. Understanding My Condition

I understand that I have been diagnosed with cancer of the prostate gland. The prostate is a male gland located just below the bladder, surrounding the urethra (the tube through which urine passes). It produces fluid for semen.

The treatment plan for prostate cancer depends on several factors, including:

• The stage of the cancer (how far it has spread).

• The Grade Group (Gleason score) , which indicates how aggressive the cancer is.

• My age and overall health (fitness for surgery).

• My personal preferences after discussing all options with my doctor and family.

The goal of a Radical Prostatectomy is to remove the entire cancer and achieve a cure. The final decision about any additional treatments (such as radiation therapy) will be made after reviewing the histopathology report of the removed prostate.

3. Procedure Description

I voluntarily agree to undergo Radical Prostatectomy , performed by the team of Dr. ____________________________________________________. I understand the following about the procedure:

3.1 Extent of Surgery

• Radical Prostatectomy involves the complete removal of:

  1. The entire prostate gland.

  2. The seminal vesicles (glands that produce semen).

  3. A cuff (small segment) of the bladder neck.

  4. Possibly, the pelvic lymph nodes from the lower abdomen (pelvic lymph node dissection), which are removed and sent to pathology to check for cancer spread.

• Reconstruction (Anastomosis): After the prostate is removed, the surgeon must reconnect the bladder to the remaining part of the urethra. This is done with fine stitches to create a new connection (anastomosis).

3.2 Pre-Operative Preparation

• I will undergo a Pre-Anesthetic Checkup (PAC) to ensure I am fit for surgery and anesthesia. This involves blood tests, heart tracing (ECG), chest X-ray, and other assessments as needed.

• During the surgery, I will have monitoring lines placed, which may include:

  • Arterial Line: A small tube in an artery to continuously monitor blood pressure.

  • Central Venous Line: A tube placed in a large vein in my neck or chest to monitor fluid status and deliver medications.

3.3 Anesthesia

• The surgery will be performed under General Anesthesia, meaning I will be completely asleep and pain-free during the procedure. A breathing tube will be inserted to help me breathe (ventilator support during surgery).

3.4 Surgical Approaches
I understand that the surgeon will use one of the following methods, and I consent to either approach as deemed appropriate by the surgical team:

• Open Radical Prostatectomy (Retropubic): The surgeon will make a single incision (cut) in my lower abdomen, typically from the belly button to the pubic bone, through which the prostate is removed.

• Laparoscopic Radical Prostatectomy (Minimally Invasive): The surgeon will make 4 to 6 small incisions (usually 0.5-1.5 cm each) in my abdomen.

  • Carbon dioxide gas will be gently pumped into my abdomen to create space for the surgeon to work (pneumoperitoneum).

  • A tiny camera (laparoscope) and long, thin instruments are inserted through these small incisions to perform the surgery.

• Robotic-Assisted Laparoscopic Prostatectomy: This is a form of laparoscopic surgery where the surgeon controls robotic arms from a console for enhanced precision, 3D visualization, and finer control, which is particularly important for preserving nerves and performing the delicate anastomosis (reconnection).

3.5 Conversion from Laparoscopic to Open Surgery

• I understand that during a laparoscopic or robotic procedure, unexpected findings or complications (such as bleeding, dense scar tissue, or difficult anatomy) may arise. In such cases, the surgeon may need to convert to an open procedure by making a larger incision to safely complete the operation (approximately 5% risk). This is not a complication, but a sound surgical judgment to ensure my safety.

3.6 Nerve-Sparing Surgery

• I understand that the surgeon will attempt to preserve the nerves responsible for erections (the neurovascular bundles), which run along either side of the prostate. This is called nerve-sparing surgery.

• The ability to preserve these nerves depends on the location and extent of my cancer. If the cancer is close to or invading these nerves, the surgeon may need to remove them partially or completely to ensure all cancer is removed (a wide excision).

4. Post-Operative Care and Recovery

• Immediate Post-Op: After surgery, I will be moved to a recovery room and then to a hospital ward. I will have the following in place:

  • Urethral Catheter (Foley Catheter): A tube draining urine from my bladder through the penis. This will remain in place for approximately 14 days to allow the new connection (anastomosis) between my bladder and urethra to heal.

  • Abdominal Drain: A small tube near the incision to drain excess fluid.

  • IV Lines: For fluids and medications.

• Hospital Stay: I will remain in the hospital for approximately 3 to 7 days. This period may be extended if I experience any complications or need additional support.

• Catheter Removal: The catheter will be removed at my follow-up appointment (usually around 2 weeks after surgery). I may experience some leakage of urine initially, which is normal.

• Activity: I will be encouraged to walk soon after surgery to prevent blood clots. I must avoid heavy lifting, strenuous activity, and driving for several weeks (typically 4-6 weeks) to allow proper healing.

• Follow-Up: After discharge, I must attend regular follow-up appointments with my specialist as scheduled. This will include:

  • Checking my PSA levels (Prostate-Specific Antigen) to monitor for cancer recurrence.

  • Discussing recovery of continence and erectile function.

  • Reviewing the final histopathology report to determine if any additional treatment (such as radiation therapy or hormone therapy) is recommended.

5. Understanding of Risks and Potential Complications

I acknowledge that no surgery or medical procedure is without risk. I have been informed about the potential problems that could occur during or after the Radical Prostatectomy procedure. These include, but are not limited to:

5.1 Anesthesia and Monitoring Line Risks

• General Anesthesia: Potential reactions to drugs, allergies, blood pressure fluctuations, or heart rate changes. In rare circumstances (approximately 0.5% ), these can be life-threatening and may require ventilator support.

• Central Line Placement: Placement of a central venous line carries a small risk (approximately 0.2% ) of injury to nearby structures, such as the carotid artery, or causing a collapsed lung (pneumothorax).

5.2 Bleeding and Blood Transfusion

• Excessive bleeding during or after surgery (approximately 1-5% ) may require a blood transfusion.

• I understand that blood transfusions carry their own small risks, including allergic reactions, fever, and very rare risks of infection (approximately 5% for minor adverse effects).

• In rare cases, severe bleeding may require a return to the operating room (re-operation) to control it.

5.3 Specific Risks of Laparoscopic/Robotic Surgery

• Gas Insufflation Effects: The carbon dioxide gas used to inflate my abdomen can cause temporary shoulder pain. Rarely, it can lead to fluctuations in blood pressure or heart rateduring the procedure (approximately 5% risk of significant hemodynamic changes). The anesthesia team monitors this closely.

• Gas Embolism: A very rare but serious condition where gas enters the bloodstream.

• Conversion to Open Surgery: As mentioned in section 3.5, there is a 5% chance of needing to convert to an open procedure.

5.4 Injury to Surrounding Organs
The prostate is located near several vital structures. During surgery, there is a risk of injuring these structures (approximately 1-2% ), which may require immediate repair:

• Rectal Injury: The rectum (large bowel) lies directly behind the prostate. If it is injured, it will be repaired immediately. In some cases, a temporary colostomy (bowel diverted to a bag on the abdomen) may be needed to allow the area to heal (approximately 1% ). This is usually temporary and reversed in a second surgery.

• Ureteral Injury: The tubes (ureters) bringing urine from the kidneys to the bladder may be injured.

• Bowel Injury: The small or large intestine may be injured, potentially requiring repair or, rarely, a temporary ileostomy.

• Obturator Nerve Injury: A nerve near the lymph node dissection site may be injured, causing inner thigh numbness or weakness.

5.5 Incomplete Resection / Aborted Procedure

• In some cases (approximately 1% ), after the surgery has begun, the surgeon may find that the cancer is more advanced than expected. This could include:

  • Cancer fixed to the pelvic sidewall that cannot be safely removed.

  • Cancer spread to lymph nodes that was not detected on pre-operative scans.

• In these situations, the surgeon may decide to stop the procedure (sometimes called “open and close”) and discuss alternative treatments such as radiation and hormone therapy.

5.6 Urine Leak and Anastomotic Stricture

• Urine Leak: There is a risk that the new connection between the bladder and urethra may leak urine (approximately 5% ). This is usually managed by leaving the catheter in place longer to allow healing. Rarely, it may require a drain or re-operation.

• Anastomotic Stricture: Scar tissue may form at the connection site, causing narrowing (stricture). This can obstruct urine flow and may require further procedures such as dilation or laser incision (approximately 5% ).

5.7 Urethral Stricture

• Scarring can occur in the urethra (the tube in the penis) from the passage of the catheter or instruments, causing narrowing and difficulty urinating months or years later (approximately 1-5% ). This may require further treatment.

5.8 Functional Outcomes: Continence and Potency
I understand that the two most significant side effects of this surgery relate to urinary control and sexual function.

• Retrograde Ejaculation (“Dry Orgasm”): Because the prostate and seminal vesicles are removed, I will no longer produce semen. Orgasm will still occur, but it will be “dry” (no fluid expelled). This is permanent and expected in 100% of cases.

• Urinary Incontinence (Leakage of Urine):

  • Temporary Incontinence: Some degree of urinary leakage is very common immediately after catheter removal. This can range from mild stress incontinence (leaking with cough/sneeze) to more significant leakage. This improves significantly over weeks to months with pelvic floor exercises. The rate of temporary incontinence is 50-100% in the early post-operative period.

  • Permanent Incontinence: Long-term, persistent leakage requiring the use of pads is a known risk. The rate of permanent incontinence depends on age, pre-existing bladder function, and surgical expertise, but is approximately 5-20% for significant leakage. (Note: The original text stated 20-50% for permanent, which is high; this has been adjusted to a more standard range. Please confirm with your surgeon). Severe incontinence requiring further surgery (e.g., artificial urinary sphincter) is rare.

• Erectile Dysfunction (Impotence):

  • The nerves responsible for erections are located very close to the prostate. Even with nerve-sparing techniques, they can be bruised or damaged.

  • The likelihood of recovering erections depends on my age, pre-operative erectile function, and how extensively the nerves could be preserved. Recovery can take up to 12-24 months.

  • The risk of permanent erectile dysfunction is approximately 20-70% , depending on these factors. (Note: The original range of 20-50% is reasonable, but can be higher in older men or those with poor pre-op function).

  • Treatments for post-prostatectomy ED include medications (Viagra/Cialis), vacuum devices, injections, or penile implants.

5.9 Lymphocele Formation

• If lymph nodes are removed, fluid (lymph) can collect in the pelvis, forming a lymphocele. This may cause pain, pressure, or leg swelling. Small lymphoceles resolve on their own; large ones may require drainage.

5.10 Infection

• Wound Infection: The surgical incision(s) may become infected (approximately 4% ), requiring antibiotics or drainage.

• Urinary Tract Infection (UTI): The prolonged catheter use carries a risk of UTI.

• Sepsis (Blood Infection): A severe, body-wide infection that can be life-threatening (approximately 5% ). Sepsis requires immediate treatment with strong intravenous antibiotics and may necessitate a prolonged stay in the Intensive Care Unit (ICU).

5.11 Respiratory Complications

• Chest Infection (Pneumonia): Approximately 5% risk, especially in patients who smoke or have lung conditions.

5.12 Blood Clots (Thromboembolism)

• Deep Vein Thrombosis (DVT): Blood clots can form in the leg veins (approximately 0.5% ) due to immobility during and after surgery.

• Pulmonary Embolism (PE): If a clot travels to the lungs, it can be life-threatening. Preventative measures (blood thinners, compression stockings, early mobilization) will be used to reduce this risk.

5.13 Chronic Pain and Wound Issues

• Painful Scar and Neuralgia: The surgical scar may remain painful, numb, or sensitive for a long time (approximately 10% ).

• Incisional Hernia: The abdominal muscles may weaken at the incision site, allowing internal tissue to bulge through. This occurs in approximately 1-2% of open cases and may require future surgery to repair.

5.14 Acute Kidney Injury

• There is a small risk of temporary kidney dysfunction after surgery (approximately 1-5% ), which usually resolves with hydration.

5.15 Cancer Recurrence

• Despite complete removal of the prostate, prostate cancer can recur (come back) in the body (approximately 5-20% over 10 years, depending on the stage and grade of the original tumor).

• Recurrence is monitored by regular PSA blood tests.

• If cancer recurs, further treatment may be needed, including radiation therapy, hormone therapy (androgen deprivation therapy), or chemotherapy .

5.16 Mortality

• I understand that, as with any major surgery involving general anesthesia, there is a risk of death. For a Radical Prostatectomy, this risk is approximately 0.2-1% , depending on my overall health and age.

5.17 Other Potential Issues

6. Prognosis and Alternatives

I understand the risks of not having the surgery, which include:

• Progression and spread of the cancer (metastasis) to bones, lymph nodes, or other organs.

• Development of symptoms such as bone pain, urinary obstruction, or weight loss.

• Potential for the cancer to become incurable.

I am aware that alternative treatments have been discussed, which may include:

• Active Surveillance: Closely monitoring low-risk cancer with regular PSAs, exams, and biopsies, intervening only if it progresses.

• Radiation Therapy: External beam radiation or brachytherapy (internal seed implants), often combined with hormone therapy.

• Focal Therapy: Treating only the part of the prostate containing cancer (e.g., HIFU or cryotherapy) – available only for select patients.

• Hormone Therapy (Androgen Deprivation Therapy): Medications to lower testosterone and slow cancer growth.

Based on my condition, Radical Prostatectomy is the recommended option.

7. Patient Acknowledgement and Agreement

• Understanding and Voluntarily Consent: I confirm that I have read (or have had read to me) the information above. I understand the nature of the Radical Prostatectomy procedure, its intended benefits, and the material risks outlined. I particularly acknowledge the potential for permanent changes to my urinary control and sexual function. I believe I have sufficient information to make an informed decision, and I give my consent freely and voluntarily.

• No Guarantees: I understand that while the goal of the surgery is to remove all cancer and achieve cure, no guarantees or promises have been made to me about the results of this treatment. Medicine is not an exact science.

• Right to Change My Mind: I understand that I have the right to change my mind about having surgery at any time, even after signing this form. However, I confirm that I currently wish to proceed as discussed with my doctor.

• Acknowledgement of Responsibility: I understand that my cooperation and honesty regarding my medical history, medications, and lifestyle are essential. I agree to follow the doctor’s advice regarding post-operative care, pelvic floor exercises, follow-up appointments, and reporting any unusual symptoms.

• Emergency Situations: I consent to the medical team taking any immediate and life-saving measures necessary during the surgery, as discussed with my doctors. I am prepared for additional treatments (such as blood transfusion, intensive care, or stoma formation) in case of any complications.

I have read this form (or it has been read and explained to me) and I understand its contents.

8. Signatures

Patient:

• Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

• Thumbprint (if applicable): __________________ Time: ______________

• Contact Address & Phone: ________________________________________________________________

Witness to Patient Signature (if required):

• Name: __________________________________ Designation: __________________________________

• Signature: __________________________________ Date: ______________

Interpreter (If patient does not understand the language used):
I have interpreted the information contained in this consent form to the patient to the best of my ability and in a language they understand. The patient has indicated that they understand the information and have given their consent freely.

• Name: __________________________________ Relationship: __________________________________

• Signature: __________________________________ Date: ______________

Physician Statement:
I have explained the nature, purpose, risks, benefits, and alternatives of this Radical Prostatectomy procedure to the patient. I have answered their questions and believe they have a sufficient understanding to provide informed consent.

• Doctor’s Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

INFORMED CONSENT FOR RADICAL CYSTECTOMY (BLADDER CANCER SURGERY)

Patient Name: ____________________________________________________
Date of Birth: _____________________ Hospital/NIC Number: _____________________

1. Confirmation of Discussion

I, the undersigned, confirm that Dr. ____________________________________________________ has provided me with comprehensive information regarding my diagnosis of Muscle-Invasive Bladder Cancer and the available treatment options. The doctor has explained the nature of my condition, the proposed procedure, its intended benefits, and the material risks involved. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction.

2. Understanding My Condition

I understand that I have been diagnosed with bladder cancer that has invaded the muscle layer of the bladder wall. This is called Muscle-Invasive Bladder Cancer (MIBC) .

Because the cancer has grown deep into the bladder muscle, it cannot be completely removed by a simple scope procedure through the urethra (TURBT alone). The cancer has a high risk of spreading to other parts of the body (metastasis) if not treated aggressively.

The goal of a Radical Cystectomy is to:

1. Remove the entire cancer along with the bladder and surrounding organs.

2. Create a new way for urine to leave my body (urinary diversion).

The final decision about any additional treatments (such as chemotherapy) will be made after reviewing the histopathology report of the removed tissues.

3. Procedure Description

I voluntarily agree to undergo Radical Cystectomy , performed by the team of Dr. ____________________________________________________. I understand that this is a major, complex surgery involving two main parts: Removal (Resection) and Reconstruction (Urinary Diversion) .

3.1 Pre-Operative Preparation

• I will undergo a Pre-Anesthetic Checkup (PAC) to ensure I am fit for surgery and anesthesia. This involves blood tests, heart tracing (ECG), chest X-ray, and other assessments as needed.

• I may be required to have a bowel preparation (drinking a special solution to clean out my intestines) before surgery, depending on the surgeon’s preference.

• During the surgery, I will have monitoring lines placed, which may include:

  • Arterial Line: A small tube in an artery to continuously monitor blood pressure.

  • Central Venous Line: A tube placed in a large vein in my neck or chest to monitor fluid status and deliver medications.

3.2 Anesthesia

• The surgery will be performed under General Anesthesia, meaning I will be completely asleep and pain-free during the procedure. A breathing tube will be inserted to help me breathe (ventilator support during surgery). An epidural catheter may also be placed for post-operative pain control.

3.3 Surgical Approaches
I understand that the surgeon will use one of the following methods, and I consent to either approach as deemed appropriate by the surgical team:

• Open Radical Cystectomy: The surgeon will make a single long incision (cut) in my lower abdomen, typically from the belly button to the pubic bone.

• Laparoscopic or Robotic-Assisted Radical Cystectomy: The surgeon will make several small incisions in my abdomen. Carbon dioxide gas will be used to inflate the abdomen (pneumoperitoneum) to create space to work. A camera and long instruments are used to perform the removal. A small incision is then made to remove the organs and to perform the reconstruction.

3.4 Conversion from Laparoscopic to Open Surgery

• I understand that during a laparoscopic or robotic procedure, unexpected findings or complications may arise. In such cases, the surgeon may need to convert to an open procedureby making a larger incision to safely complete the operation (approximately 5% risk). This is not a complication, but a sound surgical judgment to ensure my safety.

4. Part One: Removal (Resection) – What Will Be Removed?

The organs removed differ between men and women due to different anatomy.

4.1 For Men (Male Cystectomy)

• The entire urinary bladder.

• The prostate gland.

• The seminal vesicles.

• A portion of the upper ureters (the tubes from the kidneys).

• The surrounding lymph nodes in the lower abdomen (pelvic lymph node dissection).

4.2 For Women (Female Cystectomy)

• The entire urinary bladder.

• A portion of the upper ureters.

• The surrounding lymph nodes in the lower abdomen.

• Depending on the extent and location of the cancer, the surgeon may also need to remove:

  • The uterus (hysterectomy).

  • The cervix.

  • The ovaries and fallopian tubes (salpingo-oophorectomy).

  • A portion of the vagina (anterior vaginectomy).

4.3 If Cancer Has Spread

• If the cancer has spread to nearby organs and it is surgically possible to remove it completely, the surgeon may also remove parts of those organs (e.g., a segment of bowel, part of the abdominal wall).

5. Part Two: Reconstruction (Urinary Diversion) – How Will Urine Leave My Body?

Because my bladder will be removed, the surgeon must create a new way for urine to be stored and passed. This is called Urinary Diversion and uses a segment of my intestine (bowel) . The options have been discussed with me:

5.1 Ileal Conduit (Urinary Diversion with a Stoma)

• The surgeon will take a small segment of my small intestine (ileum).

• One end of this intestinal segment will be connected to my ureters (the tubes from my kidneys). Urine will now flow from my kidneys, through the ureters, and into this intestinal segment.

• The other end of the intestinal segment will be brought out through an opening in my abdominal skin. This opening is called a stoma or urostomy.

• Urine will drain continuously from the stoma into a flat, waterproof bag (appliance) that sticks to my skin. I will need to learn how to care for my stoma and empty the bag regularly.

5.2 Orthotopic Neobladder (New Bladder / Pouch)

• The surgeon will take a longer segment of my intestine and reshape it into a spherical pouch (a “neobladder”).

• This pouch is placed in the same location where my original bladder was.

• The pouch is connected to my ureters above and to my urethra below (the tube through which I used to pass urine).

• This allows me to pass urine through my urethra in a near-normal way, without a permanent external bag.

• Important Considerations for Neobladder:

  • I will not feel the normal sensation of “fullness.” I will need to learn to empty the pouch on a schedule (by relaxing and straining abdominal muscles) rather than waiting for a natural urge.

  • Some people may leak urine at night (nocturnal incontinence).

  • I may need to use a catheter occasionally to empty the pouch completely.

  • This option is only possible if the cancer does not involve the urethra and if I am motivated and able to manage the self-care required.

5.3 Ureteric Stents

• After either type of reconstruction, small tubes called ureteric stents will be placed temporarily. These tubes run from my kidneys, through the ureters, and out through the new urinary system.

• They help drain urine while the connections (anastomoses) are healing and ensure nothing gets blocked.

• These are typically removed around 14 days after surgery, often in the outpatient clinic.

6. Post-Operative Care and Recovery

• Immediate Post-Op: After surgery, I will be moved to a recovery room and then to a hospital ward or Intensive Care Unit (ICU) for close monitoring. I will have the following in place:

  • Urethral Catheter (if neobladder created): To drain urine from the new bladder.

  • Ureteric Stents: Draining urine from the kidneys.

  • Abdominal Drain: A tube near the incisions to drain excess fluid.

  • Nasogastric Tube (NG Tube): A tube through my nose into my stomach to keep it empty and allow the bowel to rest and heal. This is removed once bowel function returns.

  • IV Lines: For fluids, nutrition, and medications.

• Bowel Recovery: Because a segment of intestine was used, my bowel function will be slow to return. I will not be allowed to eat or drink for several days. Nutrition will be given through an IV (Total Parenteral Nutrition – TPN) if needed until I can eat normally.

• Hospital Stay: I will remain in the hospital for approximately 5 to 10 days, or longer if I experience any complications.

• Pain Management: I will receive medications to manage post-operative pain.

• Activity: I will be encouraged to walk as soon as possible to prevent blood clots. I must avoid heavy lifting for several weeks (typically 6-8 weeks) to allow healing.

• Follow-Up: After discharge, I must attend regular follow-up appointments with my specialist. This will include:

  • Monitoring kidney function.

  • Checking for cancer recurrence with scans (CT scans) and urine tests.

  • For neobladder patients: learning to manage the new bladder and manage continence.

  • For ileal conduit patients: stoma care education and support.

7. Understanding of Risks and Potential Complications

I acknowledge that Radical Cystectomy is a major surgery with significant risks. I have been informed about the potential problems that could occur. These include, but are not limited to:

7.1 Anesthesia and Monitoring Line Risks

• General Anesthesia: Potential reactions to drugs, allergies, blood pressure fluctuations, or heart rate changes. In rare circumstances (approximately 0.5% ), these can be life-threatening and may require ventilator support.

• Central Line Placement: Placement of a central venous line carries a small risk (approximately 0.2% ) of injury to nearby structures (e.g., carotid artery) or causing a collapsed lung (pneumothorax).

7.2 Bleeding and Blood Transfusion

• Excessive bleeding during or after this major surgery is common. The risk of requiring a blood transfusion is significant (50-80% ), and a return to the operating room to control bleeding occurs in approximately 1-5% of cases.

• I understand that blood transfusions carry their own small risks, including allergic reactions, fever, and very rare risks of infection (approximately 5% for minor adverse effects).

7.3 Specific Risks of Laparoscopic/Robotic Surgery

• Gas Insufflation Effects: The carbon dioxide gas used can cause pressure on the heart and lungs, leading to fluctuations in blood pressure or heart rate (approximately 5% risk of significant hemodynamic changes).

• Gas Embolism: A very rare but serious condition where gas enters the bloodstream.

• Conversion to Open Surgery: As mentioned, a 5% chance of needing to convert to an open procedure.

7.4 Injury to Surrounding Organs (Approximately 1-5%)
The bladder is located near several vital structures. During surgery, there is a risk of injuring these structures, which may require immediate repair:

• Rectal Injury: The rectum lies behind the bladder. If injured, it will be repaired. A temporary colostomy (bowel diversion) may be needed to allow healing.

• Small/Large Bowel Injury: The intestines may be injured. Repair may require a temporary ileostomy or colostomy.

• Blood Vessel Injury: Major vessels like the iliac arteries and veins may be injured.

• Nerve Injury: Nerves controlling leg movement or sensation may be affected.

7.5 Incomplete Resection / Aborted Procedure

• In some cases (approximately 1% ), after the surgery has begun, the surgeon may find that the cancer is more advanced than expected (e.g., fixed to the pelvic wall, extensive spread throughout the abdomen). In these situations, the surgeon may decide to stop the procedure(sometimes called “open and close”) and discuss alternative treatments such as chemotherapy or radiation.

7.6 Specific Risks Related to Using the Intestine (Bowel)
Because a segment of the intestine is used for reconstruction, there are specific bowel-related risks:

• Bowel Anastomotic Leak: The two ends of the remaining intestine that were sewn back together may leak stool, causing peritonitis (abdominal infection). This requires emergency re-operation (approximately 1-5% ).

• Bowel Anastomotic Stricture: The rejoined bowel may scar and narrow, causing a blockage (bowel obstruction). This may require further surgery.

• Poor Blood Supply to the Intestinal Segment: The piece of intestine used to create the conduit or neobladder may have poor blood flow and could die (necrosis), requiring emergency re-operation to create a new diversion (approximately 5% risk).

• Prolonged Ileus (Bowel Paralysis): The bowel may be slow to “wake up” after surgery, delaying the start of eating and drinking. This may require Total Parenteral Nutrition (TPN) (nutrition through an IV) for several days (approximately 5-10% risk).

7.7 Specific Risks Related to the Urinary Reconstruction

• Uretero-Intestinal Anastomotic Leak: The connection between the ureters and the intestinal segment may leak urine. This is usually managed by leaving drains and stents in place longer, but may require re-operation (approximately 5% ).

• Uretero-Intestinal Anastomotic Stricture: The connection may scar and narrow, blocking urine flow from the kidney. This can cause kidney damage and may require balloon dilation or further surgery to correct (approximately 5-10% long-term risk).

• Neobladder-Specific Issues (if applicable):

  • Urine Leak from Neobladder: Leakage from the new bladder itself.

  • Incontinence (Leakage): Daytime leakage is common initially and improves with pelvic floor exercises. Nighttime leakage (nocturnal incontinence) can be a persistent problem.

  • Difficulty Emptying: Some patients cannot empty the neobladder completely and may need to use a catheter periodically (clean intermittent self-catheterization).

  • Metabolic Changes: Because the intestine absorbs substances differently than the bladder, there can be changes in blood chemistry (e.g., metabolic acidosis) requiring long-term medications.

  • Mucus in Urine: The intestinal segment will continue to produce mucus, which will be passed in the urine. This is normal.

7.8 Infection

• Wound Infection: The surgical incision(s) may become infected (approximately 4% ), requiring antibiotics or drainage.

• Urinary Tract Infection (UTI): Very common after this surgery due to the use of bowel in the urinary tract.

• Sepsis (Blood Infection): A severe, body-wide infection that can be life-threatening (approximately 5% ). Sepsis requires immediate treatment with strong intravenous antibiotics and may necessitate a prolonged stay in the ICU.

• Intra-Abdominal Abscess: A collection of pus in the abdomen may form, requiring drainage.

7.9 Respiratory Complications

• Pneumonia (Chest Infection): Approximately 5% risk. This is higher in smokers and those with lung disease.

7.10 Blood Clots (Thromboembolism)

• Deep Vein Thrombosis (DVT): Blood clots in the leg veins (approximately 0.5-5% ).

• Pulmonary Embolism (PE): If a clot travels to the lungs, it can be life-threatening. Preventative measures (blood thinners, compression stockings, early mobilization) will be used.

7.11 Chronic Pain and Wound Issues

• Painful Scar and Neuralgia: The surgical scar may remain painful, numb, or sensitive (approximately 10% ).

• Incisional Hernia: The abdominal muscles may weaken at the incision site, allowing internal tissue to bulge through. This occurs in approximately 1-10% of cases and may require future surgery to repair.

• Stoma-Related Issues (if applicable): Skin irritation, parastomal hernia (bulge around the stoma), or stoma narrowing.

7.12 Acute Kidney Injury

• There is a risk of temporary or permanent kidney dysfunction after surgery (approximately 1-5%), due to factors like dehydration, blockage, or infection.

7.13 Sexual Function

• Men: Removal of the prostate and seminal vesicles causes erectile dysfunction (inability to have natural erections) and dry orgasm (no ejaculation). Treatments such as medications, injections, or implants may help with erections.

• Women: Removal of the bladder, urethra, and potentially the uterus, ovaries, and part of the vagina can affect sexual function, including sensation, lubrication, and the ability to have intercourse. Vaginal reconstruction may be performed, but changes are common.

7.14 Cancer Recurrence

• Despite complete removal of the bladder, bladder cancer can recur (come back) in the body (approximately 5-50% over time, depending on the stage and grade of the original tumor).

• Recurrence can happen in the pelvic area or in distant organs (lungs, bones, liver).

• If cancer recurs, further treatment may be needed, including chemotherapy, radiation therapy, or immunotherapy .

7.15 Mortality

• I understand that Radical Cystectomy is a high-risk surgery. The risk of death from the procedure itself is approximately 1-3% , depending on my age and overall health.

7.16 Other Potential Issues

8. Prognosis and Alternatives

I understand the risks of not having the surgery, which include:

• Progression and spread of the cancer (metastasis) to other organs.

• Pain, bleeding from the tumor, and ureteric obstruction leading to kidney failure.

• Death from metastatic cancer.

I am aware that alternative treatments have been discussed, which may include:

• Trimodal Therapy (Bladder Preservation): A combination of maximal TURBT, radiation therapy, and chemotherapy. This aims to cure the cancer while keeping the bladder. It is an option for select patients.

• Systemic Chemotherapy Alone: For patients who are not fit for major surgery or whose cancer has already spread.

• Palliative Care: For symptom management if cure is not possible.

Based on my condition, Radical Cystectomy is the recommended option.

9. Patient Acknowledgement and Agreement

• Understanding and Voluntarily Consent: I confirm that I have read (or have had read to me) the information above. I understand the nature of the Radical Cystectomy procedure, including the removal of organs and the creation of a urinary diversion (ileal conduit or neobladder). I understand the intended benefits and the material risks outlined. I particularly acknowledge the significant impact this surgery will have on my body function and lifestyle. I believe I have sufficient information to make an informed decision, and I give my consent freely and voluntarily.

• No Guarantees: I understand that while the goal of the surgery is to remove all cancer and achieve cure, no guarantees or promises have been made to me about the results of this treatment. Medicine is not an exact science.

• Right to Change My Mind: I understand that I have the right to change my mind about having surgery at any time, even after signing this form. However, I confirm that I currently wish to proceed as discussed with my doctor.

• Acknowledgement of Responsibility: I understand that my cooperation and honesty regarding my medical history, medications, and lifestyle are essential. I agree to follow the doctor’s advice regarding post-operative care, follow-up appointments, and reporting any unusual symptoms.

• Emergency Situations: I consent to the medical team taking any immediate and life-saving measures necessary during the surgery, as discussed with my doctors. I am prepared for additional treatments (such as blood transfusion, intensive care, re-operation, or stoma formation) in case of any complications.

I have read this form (or it has been read and explained to me) and I understand its contents.

10. Signatures

Patient:

• Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

• Thumbprint (if applicable): __________________ Time: ______________

• Contact Address & Phone: ________________________________________________________________

Witness to Patient Signature (if required):

• Name: __________________________________ Designation: __________________________________

• Signature: __________________________________ Date: ______________

Interpreter (If patient does not understand the language used):
I have interpreted the information contained in this consent form to the patient to the best of my ability and in a language they understand. The patient has indicated that they understand the information and have given their consent freely.

• Name: __________________________________ Relationship: __________________________________

• Signature: __________________________________ Date: ______________

Physician Statement:
I have explained the nature, purpose, risks, benefits, and alternatives of this Radical Cystectomy procedure to the patient. I have answered their questions and believe they have a sufficient understanding to provide informed consent.

• Doctor’s Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

INFORMED CONSENT FOR PARTIAL NEPHRECTOMY (KIDNEY CANCER SURGERY)

Patient Name: ____________________________________________________
Date of Birth: _____________________ Hospital/NIC Number: _____________________

1. Confirmation of Discussion

I, the undersigned, confirm that Dr. ____________________________________________________ has provided me with comprehensive information regarding my diagnosis of a Renal Mass / Kidney Tumor and the available treatment options. The doctor has explained the nature of my condition, the proposed procedure, its intended benefits, and the material risks involved. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction.

2. Understanding My Condition

I understand that a mass or tumor has been found in my kidney. Based on my CT scan report:

• Approximately 80% of such tumors are cancerous (malignant).

• Approximately 20% may be non-cancerous (benign).

Because of this, a separate biopsy before surgery is often not required, except in special circumstances. The final diagnosis will be confirmed by the histopathology report after the tumor is removed.

The goal of a Partial Nephrectomy (Nephron-Sparing Surgery) is to:

1. Completely remove the tumor (cancer) while leaving as much healthy kidney tissue as possible.

2. Preserve kidney function, which is important for long-term health and to reduce the risk of chronic kidney disease.

3. Procedure Description

I voluntarily agree to undergo Partial Nephrectomy , performed by the team of Dr. ____________________________________________________, to remove the tumor from my RIGHT / LEFTkidney. I understand the following about the procedure:

3.1 Pre-Operative Preparation

• I will undergo a Pre-Anesthetic Checkup (PAC) to ensure I am fit for surgery and anesthesia. This involves blood tests, heart tracing (ECG), and chest X-ray as needed.

• The surgery will be performed by a team consisting of my urologist, an anesthesiologist, and other specialists as required.

3.2 Anesthesia

• The surgery will be performed under General Anesthesia, meaning I will be completely asleep and pain-free during the procedure. A breathing tube may be inserted to help me breathe (ventilator support during surgery).

3.3 Surgical Approaches
I understand that the surgeon will use one of the following methods, and I consent to either approach as deemed appropriate by the surgical team:

• Open Partial Nephrectomy: The surgeon will make a single incision (cut) in my flank (side) or abdomen, typically 10-20 cm long, through which the tumor is removed.

• Laparoscopic Partial Nephrectomy (Minimally Invasive): The surgeon will make 3 to 4 small incisions (usually 0.5-1.5 cm each) in my abdomen.

  • Carbon dioxide gas will be gently pumped into my abdomen to create space for the surgeon to work (pneumoperitoneum).

  • A tiny camera (laparoscope) and long, thin instruments are inserted through these small incisions to perform the surgery.

• Robotic-Assisted Partial Nephrectomy: This is a form of laparoscopic surgery where the surgeon controls robotic arms from a console for enhanced precision, which is particularly helpful for delicate dissection and suturing (repairing the kidney).

3.4 Hilar Clamping (Warm Ischemia)

• To remove the tumor with minimal bleeding, the surgeon will temporarily clamp (block) the blood vessels supplying that part of the kidney. This is called hilar clamping.

• The time the kidney is without blood flow is called warm ischemia time. The surgeon will work quickly to minimize this time and protect the remaining kidney function.

3.5 Conversion from Laparoscopic to Open Surgery

• I understand that during a laparoscopic procedure, unexpected findings or complications may arise. In such cases, the surgeon may need to convert to an open procedure by making a larger incision to safely complete the operation (approximately 5% risk). This is not a complication, but a sound surgical judgment to ensure my safety.

3.6 Conversion to Radical Nephrectomy

• During the surgery, if the surgeon finds that the tumor is larger than expected, is located in a very difficult position, or if there is excessive bleeding that cannot be controlled, it may be necessary to remove the entire kidney instead of just the tumor. This is called conversion to a Radical Nephrectomy (approximately 1-5% risk).

3.7 Ureteric Stent Placement

• Depending on the location of the tumor (especially if it is near the drainage system of the kidney), the surgeon may place a temporary ureteric stent (DJ stent) . This tube runs from the kidney to the bladder to drain urine and protect the repair while it heals.

• If placed, the stent is typically removed around 2 weeks after surgery in the outpatient clinic.

4. Post-Operative Care and Recovery

• Hospital Stay: After the surgery, I will be moved to a recovery room and then to a hospital ward. I will likely remain in the hospital for 3 to 7 days, depending on my recovery.

• Drains and Tubes: I may have a surgical drain (to remove excess fluid) and a urinary catheter in place for a few days after surgery.

• Pain Management: I will receive medications to manage post-operative pain.

• Activity: I will be encouraged to walk and move around soon after surgery to prevent blood clots, but I will need to avoid heavy lifting for several weeks (typically 4-6 weeks) to allow the kidney to heal.

• Follow-Up: After discharge, I must attend regular follow-up appointments with my specialist. This will include:

  • Checking my kidney function with blood tests.

  • Monitoring for cancer recurrence with periodic scans (CT or ultrasound).

  • Reviewing the final histopathology report.

5. Understanding of Risks and Potential Complications

I acknowledge that no surgery or medical procedure is without risk. I have been informed about the potential problems that could occur during or after the Partial Nephrectomy procedure. These include, but are not limited to:

5.1 Anesthesia-Related Risks

• Potential reactions to anesthetic drugs, including allergies, significant drops in blood pressure, or heart rate fluctuations.

• In rare circumstances (approximately 0.5% ), these issues can be life-threatening and may require the use of a breathing machine (ventilator) or other life-support measures.

5.2 Bleeding and Blood Transfusion

• Excessive bleeding during or after surgery (approximately 1-5% ) may require a blood transfusion.

• I understand that blood transfusions carry their own small risks, including allergic reactions, fever, and very rare risks of infection (approximately 5% for minor adverse effects).

• In cases of severe bleeding, a return to the operating room (re-operation) may be needed to control it.

5.3 Conversion to Radical Nephrectomy

• As mentioned in section 3.6, there is a 1-5% chance that the surgeon may need to remove the entire kidney instead of just the tumor. This is done to ensure my safety and to completely remove the cancer.

5.4 Urine Leak (Urinoma)

• After removing the tumor, the remaining kidney tissue must be sutured (sewn) closed. There is a risk that urine may leak from the repair site (approximately 1-5% ). This is called a urinoma.

• Small leaks may resolve on their own with conservative management (prolonged drainage).

• Larger leaks may require:

  • Placement of a ureteric stent to drain urine and allow the leak to heal.

  • Percutaneous drainage (placing a tube through the skin to drain the collected urine).

  • Rarely, re-operation to repair the leak.

5.5 Specific Risks of Laparoscopic/Robotic Surgery

• Gas Insufflation Effects: The carbon dioxide gas used to inflate my abdomen can cause temporary shoulder pain. Rarely, it can lead to fluctuations in blood pressure or heart rateduring the procedure (approximately 5% risk of significant hemodynamic changes). The anesthesia team monitors this closely.

• Gas Embolism: A very rare but serious condition where gas enters the bloodstream.

• Conversion to Open Surgery: As mentioned in section 3.5, there is a 5% chance of needing to convert to an open procedure.

5.6 Injury to Surrounding Organs and Structures
The kidney is located near several major organs. During surgery, there is a small risk of injuring these structures (approximately 1% ), which may require immediate repair or a separate re-operation:

• Right-Sided Surgery: Risk of injury to the Liver, Duodenum (first part of the small intestine), Inferior Vena Cava (IVC) , and Pleura (lining of the lung).

• Left-Sided Surgery: Risk of injury to the Spleen, Pancreas, Colon (large intestine), and Pleura.

• Major Blood Vessels: The Renal Artery and Vein, Aorta, and Inferior Vena Cava are at risk.

5.7 Involvement of Adjacent Organs

• If the cancer has spread to nearby organs and it is surgically possible to remove it completely, the surgeon may also remove parts of those organs along with the kidney tumor (approximately 5% risk). This is called a multi-visceral resection.

5.8 Incomplete Resection / Aborted Procedure

• In some cases (approximately 1% ), after the surgery has begun, the surgeon may find that the cancer is more advanced than expected (e.g., spread throughout the abdomen). In these situations, the surgeon may decide to stop the procedure (aborted surgery) and discuss alternative treatments.

5.9 Positive Margins (Incomplete Tumor Removal)

• After surgery, the histopathology report will examine the edges (margins) of the removed tissue.

• If cancer cells are found at the edge of the removed tissue (positive margin), this means the entire tumor may not have been completely removed (approximately 1-5% risk).

• Depending on the nature of the cancer and the positive margin, further treatment may be needed. This could include:

  • Close monitoring with regular scans.

  • Repeat surgery (re-operation).

  • Tumor ablation (freezing or burning).

  • Systemic therapy (targeted therapy or immunotherapy).

5.10 Infection

• Wound Infection: The surgical incision(s) may become infected (approximately 4% ), requiring antibiotics or drainage.

• Urinary Tract Infection (UTI): If a stent or catheter is placed, there is a risk of UTI.

• Sepsis (Blood Infection): A severe, body-wide infection that can be life-threatening (approximately 5% ). Sepsis requires immediate treatment with strong intravenous antibiotics and may necessitate a prolonged stay in the Intensive Care Unit (ICU).

5.11 Respiratory Complications

• Chest Infection (Pneumonia): Approximately 0.5% risk, especially in patients who smoke or have lung conditions.

• Pleural Injury: If the pleura (lung lining) is injured, air or fluid may collect around the lung (pneumothorax or pleural effusion), requiring a chest tube for drainage.

5.12 Blood Clots (Thromboembolism)

• Deep Vein Thrombosis (DVT): Blood clots can form in the leg veins (approximately 0.5% ) due to immobility during and after surgery.

• Pulmonary Embolism (PE): If a clot travels to the lungs, it can be life-threatening. Preventative measures (blood thinners, compression stockings, early mobilization) will be used to reduce this risk.

5.13 Chronic Pain and Wound Issues

• Painful Scar and Neuralgia: The surgical scar may remain painful, numb, or sensitive for a long time (approximately 10% ).

• Incisional Hernia: The abdominal muscles may weaken at the incision site, allowing internal tissue to bulge through. This occurs in approximately 1-2% of cases and may require future surgery to repair.

5.14 Kidney Function and Renal Failure

• The goal of partial nephrectomy is to preserve kidney function. However, there is still a risk of Acute Kidney Injury (AKI) after surgery (approximately 1-5% ), where the remaining kidney tissue is stressed and may temporarily not work well.

• Important Note for Patients with a Single Kidney: If I have only one kidney (solitary kidney), the risk of temporary or permanent kidney failure is higher (approximately 10% ). This could require temporary or permanent dialysis.

5.15 Cancer Recurrence

• Despite complete removal of the tumor, kidney cancer can recur (come back) in the body (approximately 5% over time, depending on the stage and grade of the original tumor).

• Recurrence can happen in the remaining kidney tissue, in the surgical bed, or in distant organs (lungs, bones, liver).

• If cancer recurs, further treatment may be needed, including repeat surgery, ablation, targeted therapy, or immunotherapy .

5.16 Mortality

• I understand that, as with any major surgery involving general anesthesia, there is a small risk of death. For a Partial Nephrectomy, this risk is approximately 0.2-0.5% , depending on my overall health and the complexity of the surgery.

5.17 Other Potential Issues

6. Prognosis and Alternatives

I understand the risks of not having the surgery, which include:

• Growth and spread of the cancer (metastasis).

• Potential for the cancer to become inoperable or incurable.

I am aware that alternative treatments have been discussed, which may include:

• Active Surveillance: Monitoring the tumor with regular scans (for small, slow-growing tumors in elderly or frail patients).

• Radical Nephrectomy: Removing the entire kidney (recommended for larger or more centrally located tumors).

• Thermal Ablation: Freezing (cryoablation) or burning (radiofrequency ablation) the tumor (for small tumors).

• Systemic Therapy: Targeted therapy or immunotherapy for advanced cancer.

Based on my condition, Partial Nephrectomy is the recommended option to preserve kidney function while removing the cancer.

7. Patient Acknowledgement and Agreement

• Understanding and Voluntarily Consent: I confirm that I have read (or have had read to me) the information above. I understand the nature of the Partial Nephrectomy procedure, its intended benefits, and the material risks outlined. I understand that there is a small chance the entire kidney may need to be removed. I believe I have sufficient information to make an informed decision, and I give my consent freely and voluntarily.

• No Guarantees: I understand that while the goal of the surgery is to remove all cancer and preserve kidney function, no guarantees or promises have been made to me about the results of this treatment. Medicine is not an exact science.

• Right to Change My Mind: I understand that I have the right to change my mind about having surgery at any time, even after signing this form. However, I confirm that I currently wish to proceed as discussed with my doctor.

• Acknowledgement of Responsibility: I understand that my cooperation and honesty regarding my medical history, medications, and lifestyle are essential. I agree to follow the doctor’s advice regarding post-operative care, follow-up appointments, and reporting any unusual symptoms.

• Emergency Situations: I consent to the medical team taking any immediate and life-saving measures necessary during the surgery, as discussed with my doctors. I am prepared for additional treatments (such as blood transfusion, conversion to radical nephrectomy, or stent placement) in case of any complications.

I have read this form (or it has been read and explained to me) and I understand its contents.

8. Signatures

Patient:

• Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

• Thumbprint (if applicable): __________________ Time: ______________

• Contact Address & Phone: ________________________________________________________________

Witness to Patient Signature (if required):

• Name: __________________________________ Designation: __________________________________

• Signature: __________________________________ Date: ______________

Interpreter (If patient does not understand the language used):
I have interpreted the information contained in this consent form to the patient to the best of my ability and in a language they understand. The patient has indicated that they understand the information and have given their consent freely.

• Name: __________________________________ Relationship: __________________________________

• Signature: __________________________________ Date: ______________

Physician Statement:
I have explained the nature, purpose, risks, benefits, and alternatives of this Partial Nephrectomy procedure to the patient. I have answered their questions and believe they have a sufficient understanding to provide informed consent.

• Doctor’s Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

INFORMED CONSENT FOR LIVING DONOR NEPHRECTOMY (KIDNEY DONATION SURGERY)

Donor Name: ____________________________________________________
Date of Birth: _____________________ Hospital/NIC Number: _____________________
Relationship to Recipient: ____________________________________________________

1. Confirmation of Discussion

I, the undersigned, confirm that Dr. ____________________________________________________ has provided me with comprehensive information regarding my voluntary participation as a Living Kidney Donor. The doctor has explained the nature of the donor evaluation process, the proposed donor nephrectomy surgery, its intended purpose, and the material risks involved. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction. I understand that this consent is based on mutual understanding between myself, the recipient, and the entire medical team.

2. Understanding My Role as a Living Donor

I understand that the recipient, ____________________________________________________, has End-Stage Renal Disease (ESRD) , meaning their kidneys have permanently failed. A kidney transplant offers them the best chance for a normal life.

I am voluntarily offering to donate one of my healthy kidneys to this recipient. I understand that:

• I have two healthy kidneys, and my body can function normally with just one.

• Extensive tests have been performed to confirm that I am in excellent physical and mental health and that my remaining kidney will be sufficient for me to live a healthy life.

• I have the absolute right to change my mind and withdraw from the donation process at any time, for any reason, without any penalty or judgment.

2.1 Advantages of Living Donor Transplantation
I understand that donating a kidney while alive offers significant advantages to the recipient:

• Planned Surgery: The transplant can be scheduled at a mutually convenient time, rather than as an emergency.

• Better Outcomes: Kidneys from living donors, especially biologically related ones, often have better tissue matching and typically function immediately and last longer than kidneys from deceased donors.

• Shorter Waiting Time: The recipient can avoid many years of waiting on the transplant list and the associated complications of long-term dialysis.

3. The Donor Evaluation Process

Before being approved as a donor, I underwent a thorough evaluation to ensure my safety. This included:

• Medical Tests: Blood tests, urine tests, kidney function tests, imaging scans (CT angiogram) to examine my kidney anatomy, and cardiac evaluations.

• Infectious Disease Screening: Testing for HIV, Hepatitis B, Hepatitis C, and other infections.

• Cancer Screening: Age-appropriate cancer screenings to ensure I am healthy.

• Psychosocial Evaluation: Meetings with a mental health professional or social worker to ensure I am making a free and informed decision, free from coercion or pressure, and that I understand the psychological implications of donation.

4. Procedure Description (Donor Nephrectomy)

I voluntarily agree to undergo Living Donor Nephrectomy , performed by the team of Dr. ____________________________________________________, to donate my RIGHT / LEFT kidney. I understand the following about the procedure:

4.1 Pre-Operative Preparation

• I will undergo a Pre-Anesthetic Checkup (PAC) to ensure I am fit for anesthesia and surgery.

• The surgery will be performed by a specialized team, and as soon as my kidney is removed, another surgical team will immediately prepare it for transplantation into the recipient.

4.2 Anesthesia

• The surgery will be performed under General Anesthesia, meaning I will be completely asleep and pain-free during the procedure. A breathing tube will be inserted to help me breathe (ventilator support during surgery).

4.3 Surgical Approaches
I understand that the surgeon will use one of the following methods to remove my kidney, and I consent to either approach as deemed appropriate by the surgical team:

• Open Donor Nephrectomy: The surgeon will make a single incision (cut) in my flank (side), typically 10-20 cm long, through which the kidney is removed.

• Laparoscopic Donor Nephrectomy (Minimally Invasive): This is the most common approach for living donation.

  • The surgeon will make 3 to 4 small incisions (usually 0.5-1.5 cm each) in my abdomen.

  • Carbon dioxide gas will be gently pumped into my abdomen to create space for the surgeon to work (pneumoperitoneum).

  • A tiny camera (laparoscope) and long, thin instruments are inserted through these small incisions.

  • The kidney is placed in a bag and removed through one of the small incisions, which may be slightly enlarged (usually a 5-7 cm incision low in the abdomen or around the belly button).

• Robotic-Assisted Donor Nephrectomy: A form of laparoscopic surgery where the surgeon controls robotic arms for enhanced precision.

4.4 Conversion from Laparoscopic to Open Surgery

• I understand that during a laparoscopic procedure, unexpected findings or complications (such as bleeding or difficult anatomy) may arise. In such cases, the surgeon may need to convert to an open procedure by making a larger incision to safely complete the operation (approximately 5% risk). This is not a complication, but a sound surgical judgment to ensure my safety.

4.5 After Removal

• Once my kidney is removed, it will be flushed with a cold preservation solution and immediately transported to the recipient’s operating room for transplantation.

5. Post-Operative Care and Recovery for the Donor

• Hospital Stay: I will remain in the hospital for approximately 3 to 7 days, depending on the type of surgery and my recovery.

• Pain Management: I will receive medications to manage post-operative pain.

• Activity: I will be encouraged to walk soon after surgery to prevent blood clots. I must avoid heavy lifting for several weeks (typically 4-6 weeks) to allow my body to heal.

• Follow-Up: After discharge, I must attend regular follow-up appointments. Lifelong annual health check-ups are recommended to monitor my blood pressure, urine, and kidney function to ensure my remaining kidney remains healthy.

6. Benefits of Being a Living Kidney Donor

I understand the primary benefits are psychological and emotional:

• Saving a Life: The profound satisfaction of giving the “gift of life” to a loved one.

• Improving Quality of Life: Contributing directly to the recipient’s improved health, freedom from dialysis, and increased longevity.

• Strengthening Bonds: The act of donation can create a deep and lasting positive bond between the donor, recipient, and family.

7. Understanding of Risks and Potential Complications

I acknowledge that, although I am a healthy individual, donor nephrectomy is a major surgery with significant risks. I have been informed about the potential problems that could occur. These include, but are not limited to:

7.1 Surgical and Anesthesia Risks

7.2 Long-Term Medical Risks for the Donor

• Acute Kidney Injury (AKI): The remaining kidney must work harder. In rare situations (dehydration, illness), it may be temporarily stressed. (Risk ~1%).

• End Stage Renal Disease (ESRD): The long-term risk of developing kidney failure in the remaining kidney is slightly higher than the general population, but still very low (estimated lifetime risk ~1%). This is why lifelong follow-up is essential.

• Increased Blood Pressure: Some studies suggest a slightly increased risk of developing high blood pressure later in life, which requires monitoring and management.

7.3 Psychosocial Risks

• Body Image: Surgical scars may be a concern for some donors.

• Adjustment: Some donors may experience unexpected emotional reactions after donation, including anxiety about the recipient’s health or their own.

• Lifestyle Impact: There may be temporary or permanent restrictions on certain activities (e.g., heavy lifting, contact sports) to protect the remaining kidney.

• Relationship Issues: In rare cases, if the recipient’s kidney fails, the donor may experience feelings of guilt or sadness. The donor-recipient relationship can also be affected by the complex emotions involved.

8. No Direct Medical Benefit to Donor

I understand and acknowledge that I will receive no direct medical benefit from this surgery. The sole purpose of this procedure is to help another person. The risks I am taking are entirely for the benefit of the recipient.

9. Prognosis and Alternatives for the Recipient

I am aware that if I do not donate, the recipient has alternative treatment options:

• Remaining on Dialysis (Hemodialysis or Peritoneal Dialysis).

• Waiting for a Deceased Donor Kidney (which may take many years).

• Considering another living donor.

My decision not to donate will not affect my relationship with the medical team, and the recipient will continue to receive the best possible care.

10. Patient Acknowledgement and Agreement

• Voluntary Decision: I confirm that my decision to donate my kidney is entirely voluntary. I have not been coerced, pressured, or offered any illegal financial incentive. I am donating freely out of my own free will.

• Understanding and Consent: I confirm that I have read (or have had read to me) the information above. I understand the nature of the Donor Nephrectomy procedure, its intended purpose, and the material risks outlined. I understand the lifelong implications for my health and the need for follow-up. I believe I have sufficient information to make an informed decision.

• Right to Withdraw: I understand that I have the absolute right to change my mind about donating my kidney at any time, up until the moment the surgery begins, without any negative consequences, criticism, or impact on the recipient’s care. Even after signing this form, I reserve the right to withdraw my consent.

• No Guarantees: I understand that while the surgery is performed by a highly skilled and experienced team, no guarantees can be made about the outcome for the recipient or about my own recovery.

• Emergency Situations: I consent to the medical team taking any immediate and life-saving measures necessary during the surgery, as discussed with my doctors. I am prepared for additional treatments (such as blood transfusion or re-operation) in case of any complications.

• Follow-Up Commitment: I agree to comply with recommended lifelong follow-up care to monitor my own health.

I have read this form (or it has been read and explained to me) and I understand its contents.

11. Signatures

Donor:

• Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

• Thumbprint (if applicable): __________________ Time: ______________

• Contact Address & Phone: ________________________________________________________________

Witness to Donor Signature (Independent Witness Recommended):

• Name: __________________________________ Designation: __________________________________

• Signature: __________________________________ Date: ______________

Interpreter (If donor does not understand the language used):
I have interpreted the information contained in this consent form to the donor to the best of my ability and in a language they understand. The donor has indicated that they understand the information and have given their consent freely.

• Name: __________________________________ Relationship: __________________________________

• Signature: __________________________________ Date: ______________

Physician Statement:
I have explained the nature, purpose, risks, benefits, and alternatives of this Living Donor Nephrectomy procedure to the donor. I have answered their questions and believe they have a sufficient understanding to provide informed consent. I confirm that the donor appears to be making a voluntary and uncoerced decision.

• Doctor’s Name: ____________________________________________________

• Signature: __________________________________ Date: ______________

Optional: Independent Donor Advocate (if applicable)
I, as an independent donor advocate, have met with the donor separately and confirm that they understand the risks and are donating voluntarily.

• Advocate’s Name: __________________________________ Signature: __________________________________