| CTRI Number |
CTRI/2020/01/022593 [Registered on: 02/01/2020] 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
|
Metabolic Surgery |
|
Scientific Title of Study
|
Endoscopic evaluation of Non-banded MGBP vs banded MGBP |
| 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
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
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing 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
SAIMS Campus, Indore-Ujjain State Highway, Sanwer
Road Near MR-10 Crossing Indore
MADHYA PRADESH
453111
India |
| Phone |
|
| 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 |
GERD/Barrett’s/Esophagus/Gastritis/Duodenitis/Ulcer |
GERD/Barrett’s/Esophagus/Gastritis/Duodenitis/Ulce |
| Comparator Agent |
Non-banded MGBP vs banded MGBP |
Non-banded MGBP vs banded MGBP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Non-banded MGBP vs banded MGBP |
|
| ExclusionCriteria |
| Details |
Another type of Metabolic procedures |
|
|
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 |
Find the comparative percentage of following findings
Esophagitis
2. Signs of GERD
3. Barrett’s Esophagus
4. Gastritis
5. Duodenitis
6. Ulcer
at time periods |
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)
|
02/01/2020 |
| 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
|
Mini Gastric Bypass is one of the fastest growing bariatric procedures. It has shown at least equal or better weight loss and co morbidities resolution as compared to Roux-en-Y, a gold standard bariatric procedure. There is concern that this procedure is associated with high incidence of marginal ulcers that are difficult to heal due to the constant exposure of gastro-jejunostomy to bile and pancreatic juices. To further achieve more sutained weigh loss and long term remission of comorbidities in super obese patients Gastric ring has been tried. But .Study from Australia, banded MGB resulted in a marked increase of acid reflux into the esophagus and the operation was abandoned |