| CTRI Number |
CTRI/2020/01/022627 [Registered on: 06/01/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing outcomes in Tubular Gastric bypass vs One-anastomosis gastric bypass |
|
Scientific Title of Study
|
Tubular Gastric bypass vs OAGB long term outcomes and co
morbidity resolution |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
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 |
Department of Bariatrics Surgery
Mohak Bariatrics and Robotics Centre
SAIMS Campus, Indore-Ujjain State Highway, Sanwer Road Near
MR-10 Crossing Indore
Indore
MADHYA PRADESH
453111
India |
| Phone |
9737367367 |
| 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 |
Department of Bariatrics Surgery
Mohak Bariatrics and Robotics Centre
SAIMS Campus, Indore-Ujjain State Highway, Sanwer Road Near
MR-10 Crossing Indore
Indore
MADHYA PRADESH
453111
India |
| Phone |
9737367367 |
| 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 |
Department of Bariatrics Surgery
Mohak Bariatrics and Robotics Centre
SAIMS Campus, Indore-Ujjain State Highway, Sanwer Road Near
MR-10 Crossing Indore
Indore
MADHYA PRADESH
453111
India |
| Phone |
9737367367 |
| Fax |
07314231790 |
| Email |
drmohitbhandari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mohak Bariatric and Robotics Centre |
|
|
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 |
SAIMS Campus, Indore-Ujjain State Highway, Sanwer Road Near
MR-10 Crossing Indore
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 |
| Intervention |
During the study period at each follow-up we will record nutritional deficiencies |
Malnutrition
Lifestyle modification |
| Intervention |
During the study period at each follow-up we will record outcome of co-morbidities |
Type 2 diabetic remission
Sleep Apnea remission
Dyslipidaemia |
| Intervention |
During the study period at each follow-up we will record weight loss |
Percentage of total weight loss(%TWL)
Excess body weight loss (%EWL) |
| Intervention |
Early and late complications |
Dumping syndrome, a condition that can lead to symptoms like nausea and dizziness.
Vomiting
Ulcers
Bowel obstruction
Hernias |
| Comparator Agent |
Tubular Gastric bypass vs OAGB |
Tubular Gastric bypass vs OAGB |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All Patients who underwent MGB and TGB |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Loss |
1yr,2yrs,3yrs,4yrs,5yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Early post operative complications
Long term nutritional effects /PEM
Quality of life
Marginal ulcers formation |
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)
|
10/01/2020 |
| 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
|
The mini-gastric bypass or one anastomosis gastric bypass (MGB-OAGB) is now growing Rapidly in popularity as a safe and effective procedure, with excellent control of weight and co-morbidities in long-term evaluations. However, there are some significant clinical issues. Biliary reflux, marginal ulcer. So by adding a Roux-en-Y diversion to the MGB-OAGB cases which had pathologic post-operative reflux, we were giving patients a very comfortable and effective solution.so we thought to do a comparative study of both |