| CTRI Number |
CTRI/2019/12/022561 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
31/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of laparoscopic gastric bypass (LGB) vs banded gastric bypass (BGBP) :Long-Term Outcomes |
|
Scientific Title of Study
|
LGB VS BGBP LONG TERM OUTCOMES AND COMORBIDITY
RESOLUTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not registered in some other registry |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Bhandari |
| Designation |
Director and Chief Surgeon |
| Affiliation |
Mohak Bariatric and Robotics Centre |
| Address |
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore
Indore
MADHYA PRADESH
453111
India |
| Phone |
|
| Fax |
07314231790 |
| Email |
drmohitbhandari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Bhandari |
| Designation |
Director and Chief Surgeon |
| Affiliation |
Mohak Bariatric and Robotics Centre |
| Address |
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore
Indore
MADHYA PRADESH
453111
India |
| Phone |
|
| Fax |
07314231790 |
| Email |
drmohitbhandari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Bhandari |
| Designation |
Director and Chief Surgeon |
| Affiliation |
Mohak Bariatric and Robotics Centre |
| Address |
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore
Indore
MADHYA PRADESH
453111
India |
| Phone |
|
| Fax |
07314231790 |
| Email |
drmohitbhandari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Bariatrics Surgery
Mohak Bariatrics and Robotics Centre
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore, Madhya Pradesh, India
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore, Madhya Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Mohak Bariatric and Robotics Centre |
| Address |
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohit Bhandari |
Mohak Bariatric and Robotics Center |
Department of Bariatrics Surgery
Mohak Bariatrics and Robotics Centre
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing
Indore
MADHYA PRADESH |
9737367367
07314231790
drmohitbhandari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Aurobindo Medical College and PG Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LGB VS BGBP |
LGB VS BGBP |
| Intervention |
OUTCOMES AND COMORBIDITY RESOLUTION |
OUTCOMES AND COMORBIDITY RESOLUTION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who underwent LGB and GBGP |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Losss |
1yr,2yrs,3yrs,4yrs,5yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight loss and weight loss maintenance between the two procedures |
1yr,2yrs,3yrs,4yrs,5yrs |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/01/2020 |
| 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="5"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Roux-en-Y gastric bypass (RYGB) is one of the most widely used bariatric surgeries for treatment of moderate and severe obesity. Placing a band around the pouch to band the gastric bypass operation has been reported to increase the restriction resulting in better weight loss and weight loss maintenance.Objective This study is a prospective randomized clinical trial to compare of banded versus non-banded gastric bypass was done to see if banding the pouch made a difference in the weight loss, resolution of comorbidities, long term nutritional deficiencies and quality of life outcome in the patients. |