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CTRI Number  CTRI/2024/04/065827 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of early versus conventional closure of intestinal surgery 
Scientific Title of Study   A Comparative Study Between Early and Conventional Intestinal Stoma Closure at SMS Hospital, Jaipur 
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 Hanuman Ram 
Designation  Professor 
Affiliation  Sawai Mansingh Medical College and Hospital 
Address  Room no. 118, Surgery office, first floor, sms hospital

Jaipur
RAJASTHAN
302004
India 
Phone  9460324000  
Fax    
Email  drhanumankhoja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VIJAY 
Designation  Junior Resident 
Affiliation  Sawai Mansingh Medical College and Hospital 
Address  Room no. 118, Department of general surgery, Sms hospital

Jaipur
RAJASTHAN
302004
India 
Phone  8559824997  
Fax    
Email  vjvatvani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr VIJAY 
Designation  Junior Resident 
Affiliation  Sawai Mansingh Medical College and Hospital 
Address  Room no. 118, Department of General surgery sms hospital

Jaipur
RAJASTHAN
302004
India 
Phone  8559824997  
Fax    
Email  vjvatvani@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery, SMS Medical college and Hospitals, Jaipur, Rajasthan 302004 
 
Primary Sponsor  
Name  Department of General Surgery, SMS Medical college and Hospitals 
Address  JLN Marg, Ashok Nagar, Jaipur, Rajasthan 302001 
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 VIJAY  Room no. 118, Department of General surgery, SMS HOSPITAL JAIPUR  JLN MARG, ASHOK NAGAR, JAIPUR, RAJASTHAN 302001
Jaipur
RAJASTHAN 		 8559824997

vjvatvani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS Medical College Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z933||Colostomy status, (2) ICD-10 Condition: Z932||Ileostomy status, (3) ICD-10 Condition: Z934||Other artificial openings of gastrointestinal tract status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional stoma closure  reversal of intestinal stoma at 8-12 weeks after primary surgery 
Intervention  Early stoma closure  Early reversal of intestinal stoma at 21 days after primary surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1)Patients with intestinal stoma following bowel surgery
2)Patient who will give informed consent to participate in the study 
 
ExclusionCriteria 
Details  1)Patients with coexisting malignancy
2)Severe malnourished patients
3)patients with Koch’s abdomen
4)patients with end stoma
5)patients with Diabetes/HIV
6)patients being treated with steroids
7)patients with linguistic difficulties and patients with expected low compliance. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
post operative anastomotic leak  at post op day 4 & 7 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  after 6 weeks of stoma reversal 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   01/05/2024 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Researchers who provide a methodologically sound proposal.

  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 [vjvatvani@gmail.com].

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 31-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A temporary intestinal stoma usually formed to protect distal anastomosis or as a exteriorisation of intestinal perforation where primary repair can’t be done. so timing of stoma closure is always a topic of debate. Stoma closure is usually performed after 8 -12 weeks. However quality of life is affected due to stoma-related complications during this time period.Early closure of temporary stomas may lessen patient discomfort and stoma-related morbidity. In general, intestinal continuity restoration is linked to low mortality. we believe early closure of intestinal stoma is safe and improves post operative quality of life of the patient and subsequently reduces stoma related morbidity. overall, we expect early stoma closure is superior to conventional one and this may help us to decide the timing of intestinal stoma closure.  
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