| CTRI Number |
CTRI/2026/02/104317 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized Trial in Liver Donors Comparing Upper Midline and Pfannenstiel Cuts for liver Removal After Robotic Liver Donation to compare Pain , cosmesis and quality of life. |
|
Scientific Title of Study
|
Randomized control trial on graft retrieval via upper midline incision vs Pfannenstiel incision following Modified robotic donor hepatectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Brara |
| Designation |
Senior Resident |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, South DELHI- 110017 India
South
DELHI
110017
India |
| Phone |
8197666567 |
| Fax |
|
| Email |
akshaybrara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sreejith |
| Designation |
Senior Consultant |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, South DELHI- 110017 India
South
DELHI
110017
India |
| Phone |
9946357466 |
| Fax |
|
| Email |
drssreejith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Brara |
| Designation |
Senior Resident |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, South DELHI- 110017 India
South
DELHI
110017
India |
| Phone |
8197666567 |
| Fax |
|
| Email |
akshaybrara@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Max Super Specialty Hospital |
| Address |
Room no- CLBS office, fifth floor, west block, Max Super Specialty Hospital, 1 , Press Enclave Marg, Saket Institutional Area, South, DELHI 110017, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Akshay Brara |
Max Super Specialty Hospital |
CLBS office 5th floor West Wing Max Super Specialty Hospital 1 2 Press Enclave, Saket, New Delhi, Delhi-110017
South
DELHI |
8197666567
akshaybrara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy liver donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pfannenstiel Incision (PFI) |
Low transverse incision for graft retrieval after modified robotic donor hepatectomy |
| Comparator Agent |
Upper Midline Incision (UMI)
|
Upper midline incision for graft retrieval after modified robotic donor hepatectomy
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 65 years.
2. Medically cleared for minimally invasive donor hepatectomy
3. Provided written informed consent |
|
| ExclusionCriteria |
| Details |
1. Prior abdominal surgeries precluding assigned incision.
2. Any other contraindications to laparoscopic/robotic surgery.
3. Refusal to participate or higher cost.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Chart of Visual Analogue Scale (VAS) at 6, 24, 48, 72, 96, 120hours (DAY0-DAY5).
ii. Donor quality of life estimated by WHOQOL-BREF Score at 1 month, 3 months, 6 months and 12 months
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Wound complications (infection, hematoma, dehiscence).
ii. Cosmesis by POSAS score.
iii. Cost of procedure.
iv. Hospital stay (days).
v. Re-exploration / percutaneous intervention for hemorrhage, biliary or vascular issues.
vi. Graft function (peak AST, ALT, bilirubin)
vii. Warm ischemia time (intraoperative).
|
24 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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
|
Minimally invasive donor hepatectomy (MIDH) has become increasingly popular due to its demonstrated benefits of decreased postoperative morbidity and faster recovery relative to open techniques. Among minimally invasive methods, robotic donor hepatectomy offers unparalleled surgical control, allowing meticulous dissection of critical structures such as the hepatic artery, portal vein, and biliary ducts with enhanced precision and safety. While the intra-abdominal phase has been extensively optimized through robotic systems, graft retrieval still necessitates a mini-laparotomy incision. The upper midline incision provides excellent operative exposure and is standard in many Asian centers. Conversely, the Pfannenstiel incision, located transversely in the lower abdomen, offers cosmetic and respiratory advantages by preserving upper abdominal musculature.
Thus, this study aims to evaluate donor postoperative pain, quality of life, wound complications, cosmetic outcomes, procedural costs, hospital stay, and graft function between UMI and PFI after modified robotic donor hepatectomy, providing evidence-based recommendations for optimal graft retrieval incision selection in modern minimally invasive liver transplantation practice. |