| CTRI Number |
CTRI/2026/03/107095 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing pain and early recovery in patients undergoing kidney transplant surgery using robotic surgery versus open surgery |
|
Scientific Title of Study
|
Randomized Controlled Trial Comparing Postoperative Pain And Early Outcomes After Robotic-Assisted Versus Open Renal Transplantation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Professor Virinder Kumar Bansal |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no-405 4th Floor Surgery Block AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Arun Anand |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no-428 4th Floor Surgery Block AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
8860759615 |
| Fax |
|
| Email |
arunanand093@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yathin K |
| Designation |
PG Surgery Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no-405 4th Floor Surgery Block AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
8095226885 |
| Fax |
|
| Email |
yathin239@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Professor. Virinder Kumar Bansal |
| Address |
Room no- 405 4th floor Surgery Block AIIMS New delhi Pin- 110029 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Virinder Kumar Bansal |
AIIMS,New Delhi |
Room no- 405 4th floor Surgery block AIIMS New Delhi Pin-110029
South West
DELHI
South West
DELHI |
9810348479
drvkbansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (2) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open Renal Transplantation (ORT) |
A traditional open surgery performed through a modified Gibsons incision in the right iliac fossa. The kidney is placed extraperitoneally, with direct vascular anastomoses to the external iliac vessels. Ureteral implantation and layered fascial and skin closure complete the procedure. |
| Intervention |
Robotic-assisted kidney transplantation (RAKT) |
A minimally invasive procedure performed through a Pfannenstiel incision and laparoscopic ports. The kidney is placed intraperitoneally, with robotic anastomosis of the vessels to the external iliac artery and vein. Ureteral implantation and abdominal closure are then performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed ESRD and eligible for living-donor renal transplantation |
|
| ExclusionCriteria |
| Details |
Cadaveric or ABO-incompatible transplant.
Significant iliac vascular calcification or abnormal anatomy requiring open exposure.
Multiple vessels, left iliac fossa transplant
Vascular and ureteric anomalies of donor kidney
Prior major pelvic surgery precluding robotic access.
BMI more than 40 kilogram per meter cube (if robotic limitation).
Severe cardiopulmonary disease prohibiting pneumoperitoneum |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain (Numeric Rating Scale, NRS) at different intervals between patients undergoing robotic-assisted kidney transplantation (RAKT) and open renal transplantation (ORT). |
6, 12, 24, and 48 hours, and postoperative day 3 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess health-related quality of life (HRQOL) using KDQOL-36 and EQ-5D- 5L. |
At baseline, and 1, 3, and 6 months. |
| To compare analgesic consumption (opioid and non-opioid). |
|
| To evaluate length of hospital stay. |
|
| Cost effectiveness by QALY |
At 1, 3 and 6 months |
| To assess postoperative complications (wound-related, bleeding, seroma,anastomotic leak, rejection, and acute tubular necrosis). |
|
| To compare graft function (serum creatinine). |
at discharge and 30 days |
| Warm ischemia time (WIT 1 and WIT 2) and cold ischemia time |
Intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kidney transplantation is the definitive treatment for end-stage renal disease, traditionally via open surgery (OKT) using a large incision. While effective, OKT carries significant risks of wound complications, especially in obese or diabetic patients. Robot-assisted kidney transplantation (RAKT) was developed using the da Vinci system to address these issues. RAKT offers a magnified 3D view and precise instruments, enabling smaller incisions and potentially reducing complications. However, comparative data on RAKT versus OKT remains limited and inconsistent due to small, retrospective studies. A new randomized controlled trial aims to directly compare these approaches. Its primary outcome is postoperative pain, with secondary measures including complications, recovery, and cost-effectiveness. This trial seeks to provide robust evidence to guide clinical practice and improve patient outcomes in transplant surgery. |