| CTRI Number |
CTRI/2024/06/068810 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective study of 50 cases of Laparoscopic Roux-en-Y Gastric bypass as a day care surgery |
|
Scientific Title of Study
|
A prospective study of 50 cases of Laparoscopic Roux-en-Y Gastric bypass as a day care surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshit Kalaria |
| Designation |
Bariatric surgeon |
| Affiliation |
Khyati Multispeciality hospital, Ahmedabad |
| Address |
Khyati Multispeciality hospital,
S G Highway
Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
7575818155 |
| Fax |
|
| Email |
drdarshitkalaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshit Kalaria |
| Designation |
Bariatric surgeon |
| Affiliation |
Khyati Multispeciality hospital, Ahmedabad |
| Address |
Khyati Multispeciality hospital,
S G Highway,
Ahmedabad
GUJARAT
380015
India |
| Phone |
7575818155 |
| Fax |
|
| Email |
drdarshitkalaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshit Kalaria |
| Designation |
Bariatric surgeon |
| Affiliation |
Khyati Multispeciality hospital, Ahmedabad |
| Address |
Khyati Multispeciality hospital,
S G Highway,
Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
7575818155 |
| Fax |
|
| Email |
drdarshitkalaria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Khyati Multispeciality hospital, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Khyati Multispeciality hospital |
| Address |
Khyati Multispeciality hospital,
S G Highway,
Ahmedabad |
| 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 Darshit kalaria |
Khyati Multispeciality hospital |
Department of Bariatric surgery,
Khyati Multispeciality hospital, S G Highway, Ahmedabad
Ahmadabad
GUJARAT |
7575818155
drdarshitkalaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gastro Plus Ethics Committee situated at Gastro Plus Hospital D-Block 3rd Floor, Galaxy Bazaar, Sunrise Park Road Vastrapur Ahmedabad Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
o Age upto 50years
o BMI between 35-50
o Residing within a maximum of 45 minutes travel time to the hospital
o Ability to understand and use remote medical devices |
|
| ExclusionCriteria |
| Details |
1.Poorly controlled diabetes mellitus
2.History of IHD
3.History of severe pulmonary disease or OSA with AHI more than 15 or use of CPAP
4.History of DVT or thromboembolism. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Daycare Laparoscopic Roux-en-Y Gastric bypass is a feasible and safe procedure if patients are carefully and correctly selected. |
Post operative day 1, 3, 7, 14, 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient having difficulty in managing post operatively at home |
During 1st week of post operative period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/06/2024 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will observe the outcome and feasibility of patients operated for Roux-en-Y Gastric bypass as a daycare surgery and to compare the outcome with the general data
|