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Informed Consent For Surgical Operation / Procedure
Procedure: Left Radio-Cephalic AV Fistula Creation
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
The radial artery is connected to the cephalic vein at the wrist/forearm to create a vascular access suitable for haemodialysis.
The procedure may be performed under local, regional or general anaesthesia depending on clinical need.
4. Benefits and Indications
The procedure may be performed to create permanent vascular access for haemodialysis in patients with kidney failure.
The intended benefits include:
- Creation of long-term vascular access for haemodialysis.
- Better long-term dialysis access compared with central venous catheters.
- Lower infection risk compared with dialysis catheters.
- Improved dialysis adequacy.
- Improved vascular-access durability.
No guarantee can be given regarding successful maturation or long-term patency.
5. Risks and Complications
- Intra-operative
- Bleeding: 2–10%
- Blood transfusion may rarely be required: <1–2%
- Injury to artery or vein: 1–5%
- Arterial spasm/poor flow: 2–5%
- Nerve injury/numbness: 1–3%
- Change in planned site/type of fistula: 5–15%
- Failure to create a usable fistula: 2–10%
- Infection: <2–5%
- Allergic or anaesthesia-related complications: <1–2%
- ICU care: rare, <1%
- Rare risk of death: <1%
- Post-operative
- Pain, swelling or bruising. Wound infection: 2–5%
- Haematoma/seroma: 2–10%
- Fistula thrombosis: 5–20%
- Failure of fistula maturation: 20–40%
- Poor flow/non-functioning fistula requiring further procedure: 10–30%
- Steal syndrome: 1–5%
- Hand oedema/venous hypertension: 2–10%
- Pseudoaneurysm/aneurysmal dilatation: 1–5%
- Stenosis requiring angioplasty/revision: 10–30%
- Reoperation/revision/alternate access: 10–30%
- Scarring/cosmetic deformity. Rare distal ischaemia or tissue loss: <1%
- Fistula Maturation and Future Function
- The fistula may not be usable immediately.
- It requires several weeks to mature before dialysis use.
- Follow-up examination and ultrasound may be required.
- Angioplasty, revision or other procedures may be required if maturation or function is inadequate.
- The fistula may clot, fail or stop functioning even after successful surgery.
- An alternative dialysis-access procedure may be required if this fistula fails.
6. Postoperative Course
I understand that:
- Keep the limb elevated.
- Avoid blood-pressure measurement on the operated arm.
- Avoid venepuncture/blood sampling from the fistula arm.
- Monitor the fistula for thrill/bruit.
- Watch for signs of infection or reduced blood supply to the hand.
7. Alternatives to Procedure
I have been informed of alternatives including:
- Conservative management if dialysis is not yet required.
- Temporary or tunnelled central venous catheter.
- AV graft.
- Alternative AV fistula, such as:
- Brachiocephalic AV fistula
- Brachiobasilic AV fistula
- The choice depends on vascular anatomy, urgency of dialysis and overall medical condition.
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.”
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: _________________________________________
