| CTRI Number |
CTRI/2010/091/001356 [Registered on: 14/09/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Gastric Imbrications versus Sleeve Gastectomy for weight loss. |
|
Scientific Title of Study
|
Randomized Single Blinded Trial of Gastric Imbrication versus Sleeve Gastrectomy for WeighT Loss |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIGS - GISGWT - 0001 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Mahendra Narwaria |
| Designation |
|
| Affiliation |
|
| Address |
ASIAN Surgicenter
1st Floor, Silver Point,
Ahmadabad
GUJARAT
380 009
India |
| Phone |
91 79 6606 999 |
| Fax |
079 26461431 |
| Email |
narwaria@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mahendra Narwaria |
| Designation |
|
| Affiliation |
|
| Address |
ASIAN Surgicenter
1st Floor, Silver Point,
Ahmadabad
GUJARAT
380 009
India |
| Phone |
91 79 6606 999 |
| Fax |
079 26461431 |
| Email |
narwaria@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr.Akash Bhavsar |
| Designation |
|
| Affiliation |
|
| Address |
B501, Krishna Complex, Opp Devashish School, Nr Rajpat Club
S.G. Highway, Ahmedabad. India.
Ahmadabad
GUJARAT
300054
India |
| Phone |
079 40054111 |
| Fax |
079 40054113 |
| Email |
ab@investigatorsforum.net |
|
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Source of Monetary or Material Support
|
| Mahendra Narwaria MS, FICS |
|
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Primary Sponsor
|
| Name |
Dr.Mahendra Narwaria MS, FICS
ASIAN Surgicenter
1st Floor, Silver Point,
Stadium Circle,
Navrangpura, Ahmedabad - 380 009
India
|
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
|
| Name |
Address |
| Daniel R. Cottam, M.D.
Salt Lake City, USA
Sunil Sharma, M.D.
Pittsburgh, PA USA
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Mahendra Narwaria |
ASIAN Surgicenter |
1st Floor, Silver Point, Stadium Circle, Navrangpura, Ahmedabad - 380 009 India-300009
Ahmadabad
GUJARAT |
079 6606 999
079 26461431
narwaria@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IBIOME Independent Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Excessive body weight, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Body Mass Index (BMI) > 35
Male or female subjects with Age > 18 and < 65 years.
Able to read and understand the ICF (English/Hindi/Gujarati) and willing to give voluntary Consent
Willing to comply with protocol requirements
|
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| ExclusionCriteria |
| Details |
Associated fatal diseases
Cancer
Liver failure
Kidney failure.
Women who are pregnant
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is Excess Weight Loss: Depending upon the type of surgery,36 % to 90 % of excess body weight will be lost over a period of 6 months to two years. Patients may lose 30 to 50 % of their excess weight in the first 6 months and ~ 77 % as early as 12 months after surgery. |
12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India=""
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 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This is a randomized Single Blinded Trial of the Gastric Imbrications surgery versus Sleeve Gastrectomy Surgery for weight loss. The main objective of this study is to provide a surgery for weight loss which is reversible and having minimum complications. Total numbers of patients for this study are 60 either male or female and having their BMI 35 or more than that. The site for this study is Asian surgicentre, Ahmedabad and study duration is of 18 months. Study visits for this trial are Screening,7 day follow up,1 month follow up,3 month follow up,6 month follow up , 9 month follow up and 1 year follow up. The tests done at these study visits are Blood investigations, X-ray, USG, Body analysis and diet chart adherence along with routine tests. The outcome measurement is Excess weight loss up to 70 % in 12 months. |