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CTRI Number  CTRI/2024/06/069450 [Registered on: 25/06/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Research study on patients who undergo ileostomy operation by taking one litre of oral rehydration salt solution daily for four weeks after operation to prevent high water output from stoma 
Scientific Title of Study   Prophylactic use oral rehydration solution to prevent high stoma output after ileostomy A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajeevan Philip Sridhar 
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of General Surgery Unit 2 Office, Paul Brand Building, CMC Hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8870427408  
Fax    
Email  rajeevanps@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajeevan Philip Sridhar 
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of General Surgery Unit 2 Office, Paul Brand Building, CMC Hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8870427408  
Fax    
Email  rajeevanps@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajeevan Philip Sridhar 
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of General Surgery Unit 2 Office, Paul Brand Building, CMC Hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8870427408  
Fax    
Email  rajeevanps@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Ida Scudder Road, Vellore, India - 632004 
 
Primary Sponsor  
Name  Rajeevan Philip Sridhar 
Address  Department of General Surgery Unit 2 Office, Paul Brand Building, CMC Hospital, Vellore - 632004 
Type of Sponsor  Other [Self] 
 
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 Rajeevan Philip Sridhar  Christian Medical College, Vellore  Department of General Surgery Unit 2, Christian Medical College, Vellore - 632004
Vellore
TAMIL NADU 
8870427408

rajeevanps@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (Silver Ethics and Research Committee) of the Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control arm   No additional ORS taken by patients randomised to this arm.  
Intervention  Prophylactic ORS administration  One packet (21 gm) of (Oral rehydration salt)ORS powder mixed and taken with 1 litre of water (once daily, route of administration - oral) for 4 weeks duration additional to normal diet by patients randomised in this arm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consecutive patients who have an ileostomy creation
operation for any indication. All who provide written consent to take part in the study will be included. Patients undergoing both elective and emergency surgeries will be included. 
 
ExclusionCriteria 
Details  Patients with renal failure, heart failure, jejunostomy and history of previous small bowel resection 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of high output stoma  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of dehydration symptoms  4 weeks 
Incidence of electrolyte imbalance  3 weeks 
Incidence of renal impairment  3 weeks 
Readmission rate  4 weeks 
Time taken for resolution if patient develops high output stoma  4 weeks 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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 3 
Date of First Enrollment (India)   15/07/2024 
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="3"
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 - NO
Brief Summary  
An ileostomy is a common surgical procedure after major colorectal resections. This is done in patients who are unsuitable for anastomosis or as a covering procedure to protect a fragile anastomosis. One of the most common complications of ileostomy is a high stoma output. High-output stoma can lead to dehydration, electrolyte imbalance, renal impairment and readmission. Oral rehydration solution (ORS) is widely used to treat dehydration and high stoma output.

In our study, we look at the prophylactic use of ORS solution administration to prevent high output stoma and its complications in patients with an ileostomy creation. All consenting patients who have an ileostomy created will be included. Patients will be
randomised into two groups postoperatively in the postoperative period. One group of patients will receive 1 litre of prophylactic ORS solution per day, in addition to a normal diet, in the immediate postoperative period for 4 weeks, and the other group will receive routine care. Incidence of high output stoma, dehydration, electrolyte imbalance and readmission will be recorded in both groups. Patients will be contacted at 2, 3 and 4 weeks (in person or telephonic), and blood tests will be done at week 3. Both groups will be followed up for 4 weeks.
 
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