| CTRI Number |
CTRI/2026/01/100019 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Robotic Sleeve Gastrectomy vs Laparoscopic Sleeve Gastrectomy |
|
Scientific Title of Study
|
Robotic Sleeve Gastrectomy vs Laparoscopic Sleeve Gastrectomy (ROLASG): A Randomized controlled trial |
| Trial Acronym |
ROLASG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asuri Krishna |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4th floor,
Department of Surgical Disciplines,
Surgery Block,
AIIMS,
Ansari Nagar
South
DELHI
110029
India |
| Phone |
7798118327 |
| Fax |
|
| Email |
kd6011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asuri Krishna |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4th floor,
Department of Surgical Disciplines,
Surgery Block,
AIIMS,
Ansari Nagar
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karan Dharamsi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4th floor,
Department of Surgical Disciplines
Surgical block,
AIIMS,
ANSARI nagar
South
DELHI
110029
India |
| Phone |
7798118327 |
| Fax |
|
| Email |
kd6011@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Karan Dharamsi |
| Address |
4th Floor,
Department of Surgical Disciplines
Surgery Block,
AIIMS,
Ansari Nagar,
New Delhi - 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 |
| Karan Dharamsi |
AIIMS |
4th floor,
Department of Surgical Disciplines,
Surgery Block,
AIIMS,
Ansari Nagar,
New Delhi
South
DELHI |
7798118327
kd6011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic Sleeve Gastrectomy |
Patients undergoing Laparoscopic Sleeve Gastrectomy after randomization |
| Intervention |
Robotic Sleeve Gastrectomy |
Patients undergoing Robotic Sleeve Gastrectomy after randomization |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients eligible to undergo a sleeve gastrectomy based on the IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2022 patient selection guidelines.
|
|
| ExclusionCriteria |
| Details |
Previous bariatric surgeries
Barrett’s Esophagus
LA grade C or D esophagitis
Peptic stricture
Severe GERD symptoms
Opting for bariatric surgery other than sleeve gastrectomy |
|
|
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 operative time between robotic sleeve gastrectomy and laparoscopic sleeve gastrectomy. |
At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative outcomes - bleeding, time for staple line hemostasis, conversion to laparoscopy/laparotomy, surgeon ergonomics |
At the end of surgery |
| Post operative outcomes - Early post-operative pain, 30-day morbidity, 30-day re-admissions, post-operative hospital stay & Weight loss at 3 months & 6 months. |
Early post operative pain - at 24 hours after surgery
30-day morbidity - at 30 days after surgery
30- day readmissions - at 30 days after surgery
Post operative hospital stay (in hours) - at the time of discharge
Weight loss - at 3 months & 6 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
15/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Existing literature demonstrates that RSG typically has longer operative times than LSG, primarily due to docking and learning-curve factors. However, with increasing experience and workflow optimization, this difference appears to narrow. A well-conducted RCT is necessary to establish whether robotic technology can indeed enhance efficiency to achieve a statistically significant reduction in operative time. The findings will have important implications for operating-room efficiency, surgeon ergonomics, and cost-effectiveness in modern bariatric surgery practice.
|