| CTRI Number |
CTRI/2020/01/022625 [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
|
Comparison of Banded One Anastomosis Gastric Bypass vs Metabolic Gastric Bypass |
|
Scientific Title of Study
|
Banded One Anastomosis Gastric Bypass vs Metabolic Gastric
Bypass: A randomized control trial at a single institution |
| 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
|
| 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 |
|
|
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 |
| Comparator Agent |
Banded One Anastomosis Gastric Bypass vs Metabolic Gastric Bypass |
Banded One Anastomosis Gastric Bypass vs Metabolic Gastric Bypass |
| 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Banded One Anastomosis Gastric Bypass vs Metabolic Gastric Bypass |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Loss |
1yr,2yrs,3yrs,4yrs,5yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to prove the superiority of one procedure over the other for weight loss in terms of sustained weight loss and resolution of co morbidities |
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
|
Which procedure is better RYGB or Banded OAGB. Multiple studies show both can be effective in treating the morbidly obese. This study will attempt to prove the superiority of one procedure over the other for weight loss in terms of sustained weight loss and resolution of co morbidities. |