| CTRI Number |
CTRI/2016/05/006933 [Registered on: 13/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
09/05/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Open-label, Observational, Retrospective & Prospective |
| Study Design |
Other |
|
Public Title of Study
|
National Bariatric Registry of India |
|
Scientific Title of Study
|
National Bariatric Registry with OSSI
(Open-label, Observational, Retrospective & Prospective, Real-time data capturing of Usage, Outcome in Bariatric & Metabolic surgery)
|
| Trial Acronym |
OSSI National Bariatric Registry |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Khullar |
| Designation |
Senior Consultant, President OBESITY AND METABOLIC SURGERY SOCIETY OF INDIA(OSSI) |
| Affiliation |
Max Healthcare |
| Address |
2, Press Enclave Road, Max Super Speciality Hospital, saket
South
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
drrajeshkhullar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Khullar |
| Designation |
Senior Consultant, President- OBESITY AND METABOLIC SURGERY SOCIETY OF INDIA(OSSI) |
| Affiliation |
Max Healthcare |
| Address |
2, Press Enclave Road, Max Super Speciality Hospital, saket
South
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
drrajeshkhullar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Khullar |
| Designation |
Senior Consultant, President- OBESITY AND METABOLIC SURGERY SOCIETY OF INDIA(OSSI) |
| Affiliation |
Max Healthcare |
| Address |
2, Press Enclave Road, Max Super Speciality Hospital, saket
South
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
drrajeshkhullar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEVKI DEVI FOUNDATION |
| Address |
1,2 PRESS ENCLAVE MARG, MAX SUPER SPECIALITY HOSPITAL, NEW DELHI 110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 RAJESH KHULLAR |
Room no. 1, 5th floor OPD |
Max Institute of Minimal Access, Metabolic & Bariatric Surgeyr. 1,2 PRESS ENCLAVE ROAD, MAX SUPER SPECIALITY HOSPITAL, SAKET, NEW DELHI 110017
South
DELHI |
9810071046
drrajeshkhullar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with morbid obesity with a BMI (Body mass index) 32.5 kg/m2 with associated co morbidities like Diabetes, hypertension etc or BMI37.5 kg/m2 with or without any associated co morbidities. , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 All age group of patients undergoing Bariatric & Metabolic Surgery
2 Any patient who has undergone any Bariatric & Metabolic Surgery like Sleeve Gastrectomy, Lap Gastric Bypass, Mini Gastrectomy, DJB, IT, as per operating surgeon’s discretion irrespective of their age
3 Patients undergoing bariatric& metabolic surgery in India under OSSI members |
|
| ExclusionCriteria |
| Details |
Patients operated by OSSI non-member surgeries will not be included.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To populate national data regarding bariatric surgery practice across India. This will include
1. Patient demography
2. History including BMI, co-morbidities & medical complications
3. Surgical record including the type of surgery including revisions, technique, length of stay, intra-op complications, and post-operative adverse events until discharge.
|
The data would be assessed at 1 year, 2 years, 3 years, 5 year, 10 year, 15 years, 20 years, 25 years from the start of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage Excess weight loss
2. Quality of life questionnaire
3. Complications
4. Re-operation
5. Stapler used
6. Morbidity / Mortality
7. Resolution of Co-morbidities |
The data would be assessed at 1 year, 2 years, 3 years, 5 year, 10 year, 15 years, 20 years, 25 years from the start of the study |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
01/08/2015 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
• The results of this registry will be published or presented at symposia and congresses. Individual investigators are encouraged to publish or disclose the data generated at their respective sites; but only after the collective data are presented or published as a single study, or one year following either the conclusion of the registry at all sites or database lock, whichever occurs first |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
•
Information
concerning study treatments, patent applications, formulation, manufacturing
processes, unpublished scientific data, and other pertinent information is
confidential and remains the property of the manufacturer. Details will be
disclosed only to persons involved in the conduct of the registry. The
Investigator may use this information for the purposes of the registry only. •
Publication
will be made in the name of steering group and the “National Bariatric Registry
†•
Publications
that have been supported in the form of funds will require, as stated in
the study agreement, to be reviewed and approved by the Publication Committee
prior to submission for publication. The review will include a check that
there has not been any violation of obligations, and to add a disclaimer if
necessary. •
Publications
that have been supported in the form of technical input or clinical
consultation (e.g. statistical analysis, translation support, content
review etc), will also be reviewed by the Publication Committee.
•
In
the event that a publication is to include a employee from the sponsor as an
author, then the publication will also follow the review and approval process
for “Publications of Sponsored studies†and will go through the sponsor’s
internal review process. |