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CTRI Number  CTRI/2025/02/080362 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of bowel function recovery after stoma closure with or without preoperative distal loop stimulation - A Randomised controlled trial  
Scientific Title of Study   Comparison of bowel function recovery after ileostomy closure with or without preoperative bowel stimulation- A Randomised Controlled Study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shikha Baisoya 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College 
Address  Room no 208, Surgery department, 2nd Floor, BL Taneja Block, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  8588056240  
Fax    
Email  shikhabaisoya3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak Ghuliani 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Room no 208, Surgery department, 2nd Floor, BL Taneja Block, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone    
Fax    
Email  drdeepakghuliani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shikha Baisoya 
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College 
Address  Room no 208, Surgery department, 2nd Floor, BL Taneja Block, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  8588056240  
Fax    
Email  shikhabaisoya3@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical college 
Address  Surgery Department, 2nd Floor, BL Taneja Block, Maulana Azad Medical College, 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 Shikha  MAULANA AZAD MEDICAL COLLEGE  Room no 208, Department of General Surgery, Maulana Azad medical College
Central
DELHI 		 8588056240

shikhabaisoya3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana azad medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Distal bowel loop stimulation before reversal  preoperative stimulation of distal loop done with Probiotics every third day, 3 weeks prior to surgery 
Comparator Agent  stoma closure without distal loop stimulation  no preoperative distal loop given prior to stoma closure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Ptaients between 18-65 years of age

2. Patients with minimum 4 weeks duration between index procedure and ileostomy closure. 
 
ExclusionCriteria 
Details  1. Stenosis of ileostomy orifice.
2. Evidence of Distal Bowel Obstruction on Contrast study.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the recovery of bowel function after ileostomy closure with or without preoperative bowel stimulation with regards to time to passage of flatus and return of bowel sounds after surgery.  4 hours post operative 
 
Secondary Outcome  
Outcome  TimePoints 
presence of prolonged ileus in terms of intolerance of oral feed, vomiting, abdominal
distension. presence of any anastomotic leakage. post operative length of hospital stay 		 7 and 14 days. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   21/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/02/2025 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 - Proposals should be directed to [shikhabaisoya3@gmail.com].

  6. For how long will this data be available start date provided 11-12-2024 and end date provided 11-12-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To study bowel function recovery in terms of time to passage of flatus and time to return of bowel sounds, anastomotic leak, postoperative ileus and duration of hospital stay, with or without preoperative distal loop stimulation. 
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