FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068326 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 02/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   EVALUATION OF GERD IN BARIATRIC PATIENTS 
Scientific Title of Study   Evaluation of occurence of GERD in patients undergoing Bariatric Surgery using Multichannel Intraluminal Impedance pH(MII-pH) Monitoring 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
F.1/IEC/MAMC/MD/MS(96/02/2023/No.184  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHRAWAN KUMAR PRASAD 
Designation  POST GRADUATE RESIDENT  
Affiliation  MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi
Department of General Surgery, Room no 202
New Delhi
DELHI
110002
India 
Phone  9643247615  
Fax    
Email  PD.SHRAWAN25@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  SHRAWAN KUMAR PRASAD 
Designation  POST GRADUATE RESIDENT  
Affiliation  MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi
New Delhi
DELHI
110002
India 
Phone  9643247615  
Fax    
Email  PD.SHRAWAN25@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  SHRAWAN KUMAR PRASAD 
Designation  POST GRADUATE RESIDENT  
Affiliation  MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi
New Delhi
DELHI
110002
India 
Phone  9643247615  
Fax    
Email  PD.SHRAWAN25@GMAIL.COM  
 
Source of Monetary or Material Support  
MAULANA AZAD MEDICAL COLLEGE, New Delhi, india 110002 
 
Primary Sponsor  
Name  Self 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shtrawan Kumar Prasad  MAULANA AZAD MEDICAL COLLEGE  room no 202, Department of General Surgery, Maulana Azad Medical College Campus, 2, Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI 		 9643247615

pd.shrawan25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E662||Morbid (severe) obesity with alveolar hypoventilation, (2) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bariatric Surgery  Laparoscopic Sleeve Gastrectomy and Mini-Gastric Bypass 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  morbid obesity patients 
 
ExclusionCriteria 
Details  1. NON MOTIVATED INDIVIDUAL AND NON-SUPPORTIVE FAMILY/SOCIAL ENVIRONMENT.
2. IRREGULAR FOLLOW-UP IN THE METABOLIC CLINIC
3. PSYCHOLOGICALLY UNSTABLE PATIENT.
4. PREGNANCY AND LACTATION 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Detection of GERD using Multichannel Intraluminal Impedance pH (MII-pH) monitoring preoperativelY  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. DETECTION OF GERD
2. EXCESSIVE WEIGHTLOSS
3. RESOLUTION OF COMORBIDITIES 		 3 MONTHS POSTOPERATIVE 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   Phase 1 
Date of First Enrollment (India)   17/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  DELHI UNIVERSITY

  6. For how long will this data be available start date provided 10-07-2025 and end date provided 13-11-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to study the effects of Bariatric sugery on GERD. 
Close