| 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
|
|
|
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
|
|
|
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. |