Join the Youth organization of USI - The Fastest Growing Chapter of Urological Society of India. Fill out the form today!
Informed Consent For Surgical Operation / Procedure
Procedure: Donor Nephrectomy
1. Patient Identification
I, ______________________________ (patient/next of kin/legal guardian), aged ____ years, in my full senses, voluntarily authorize and give my complete consent for performance of the following procedure(s)/operation(s)/treatment(s):
Procedure: _______________________________
Diagnosis: ________________________________
Major illness & comorbidities: ________________________________
2. Authorization for Procedure
I authorize Dr. __________________ to perform the above procedure, along with such assistants and associates as may be selected by him/her.
I understand that members of the surgical team, including residents or trainees under appropriate supervision, may perform parts of the procedure according to their training and competence.
3. Nature of Procedure
A donor nephrectomy involves surgical removal of my kidney for the purpose of living kidney donation.
The procedure is usually performed laparoscopically/minimally invasively, although conversion to open surgery may sometimes be necessary.
4. Benefits and Indications
The intended benefits include:
- Voluntary donation of a kidney for transplantation.
- Potential improvement in the recipient’s survival and quality of life.
- Contribution to definitive renal replacement therapy.
I understand that the surgery is performed for the benefit of the recipient and not to treat a disease in me, and that I am accepting surgery despite being otherwise healthy.
I understand that no guarantee can be given regarding:
- The outcome of transplantation in the recipient.
- The long-term health of the recipient.
- The absence of surgical or medical complications in me.
5. Risks and Complications
- Intra-operative
- Bleeding: 2–10%
- Blood transfusion: 1–5%
- Major vascular injury involving renal vessels, aorta, vena cava or iliac vessels: 1–3%
- Injury to bowel, spleen, pancreas, liver, ureter or diaphragm: 1–5%
- Difficulty due to adhesions or abnormal anatomy.
- Prolonged surgery.
- Conversion to open surgery: 2–10%
- Anaesthesia-related complications: <1–2%
- DVT/PE: <1–2%
- ICU care: 1–5%
- Rare risk of death: approximately 0.02–0.05%, or approximately 1 in 2,000–5,000 donors.
- Post-operative
- Pain at incision/port sites.
- Wound infection: 2–5%
- Bleeding/haematoma: 1–5%
- Chest complications, including atelectasis, pleural injury or pneumonia: 1–5%
- Ileus: 2–10%
- Urinary tract infection: 1–3%
- Incisional/port-site hernia: 1–3%
- Readmission/reoperation: 1–5%
- Prolonged fatigue/delayed recovery.
- Scarring/cosmetic concerns.
- Rare chronic pain/numbness: 1–5%.
- Long-term Donor-specific Risks
- I will have only one kidney.
- Most donors live a normal, healthy life.
- There may nevertheless be a small long-term risk of reduced kidney function.
- High blood pressure may occur.
- Protein may appear in the urine.
- Pregnancy-related complications may occur in women of childbearing age.
- Rare future kidney disease may occur.
- There is a small but real possibility of future kidney disease or need for dialysis/transplant, although this is uncommon in carefully selected donors
6. Postoperative Course
I understand that lifelong follow-up is required, including:
- Blood-pressure monitoring.
- Kidney-function testing.
- Urine testing.
- General health surveillance.
I may also receive advice regarding diet, hydration, medications and avoidance of kidney injury.
I understand that:
- The surgical plan may be changed if there are concerns about my safety or the donor kidney’s safety or quality.
- In rare circumstances, the kidney may be unsuitable for transplantation because of unexpected findings or surgical problems.
- The removed kidney will be handed over for transplantation to the intended recipient/transplant team.
- I may require a urinary catheter, IV lines, pain management, blood tests and routine postoperative monitoring.
- Blood transfusion may be required if significant bleeding occurs.
- Follow-up after surgery is essential for my health and safety.
7. Alternatives to Procedure
The recipient’s alternative treatment options may include:
- Deceased-donor kidney transplantation.
- Another suitable living donor.
- Continued dialysis.
The decision regarding donation depends on my medical fitness and my free and informed willingness to donate.
8. Anaesthesia and Pain Management
I understand the risks associated with local, regional, or general anaesthesia.
Pain management options have been explained.
9. Photography / Data Use
I consent to:
☐ Medical photography/video for academic purposes
☐ Use of anonymized clinical data
10. Intraoperative Decision Consent
I authorize the surgeon to perform additional procedures considered necessary if unexpected findings arise during surgery.
11. Team-Based Care
I understand that supervised residents, fellows, or assistants may participate.
12. Patient Statement
I confirm that:
- The nature of surgery has been explained.
- Risks, benefits, and alternatives have been explained.
- My questions have been answered satisfactorily.
- I voluntarily consent.
Patient to write in own handwriting:
“I have understood the procedure, risks, benefits and alternatives explained to me in a language I understand.”
13. Donor Declaration
I confirm that:
- Donation has been explained to me.
- I understand that donation is voluntary.
- I understand that I may withdraw consent before surgery.
- I understand the risks to my own health.
- I understand that I will live with one kidney after donation.
- I understand that the procedure is being performed for the recipient’s benefit.
- I have had adequate opportunity to ask questions.
- I give my consent voluntarily and without coercion.
Signatures
Patient Name & Signature: ______________________________________
Date: ____________________ Time: ____________________
Doctor Name & Signature: ______________________________________
Date: ____________________ Time: ____________________
Witness Name & Signature: ____________________________________
Contact No.: ______________________________
ATTENDANT CONSENT (If applicable)
Reason patient unable to consent:
Attendant Name: __________________________________________
Relationship: _____________________________________________
Signature: ________________________________________________
Contact No.: ______________________________________________
INTERPRETER STATEMENT (If applicable)
I confirm an accurate explanation in understandable language.
Name: _________________________________________________
Signature: ______________________________________________
Contact: ________________________________________________
HIGH-RISK CONSENT (If applicable)
High-risk factors explained due to:
Patient Signature: ________________________________________
Doctor Signature: _________________________________________
