| CTRI Number |
CTRI/2026/01/101162 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing two standard methods of diversion stoma creation in cases of diseases requiring resection of rectum |
|
Scientific Title of Study
|
Diverting loop ileostomy versus loop colostomy in rectal resections : 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 |
Arunjeet KK |
| Designation |
PG Registrar, DrNB, SGE |
| Affiliation |
Aster Medcity |
| Address |
Department of Surgical Gastroenterology
Aster Medcity., Kochi
South Chittoor
Ernakulam, PiN 682027
Kerala
Ernakulam
KERALA
682027
India |
| Phone |
7356188222 |
| Fax |
|
| Email |
be.with.jeet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Varma |
| Designation |
Senior Consultant, SGE |
| Affiliation |
Aster Medcity |
| Address |
Department of Surgical Gastroenterology
Aster Medcity., Kochi
South Chittoor
Ernakulam, PiN 682027
Kerala
Ernakulam
KERALA
682027
India |
| Phone |
9446023075 |
| Fax |
|
| Email |
deepak.varma1@asterhospital.in |
|
Details of Contact Person
Public Query
|
| Name |
Arunjeet KK |
| Designation |
PG Registrar, DrNB, SGE |
| Affiliation |
Aster Medcity |
| Address |
Department of Surgical Gastroenterology
Aster Medcity., Kochi
South Chittoor
Ernakulam, PiN 682027
Kerala
KERALA
682027
India |
| Phone |
7356188222 |
| Fax |
|
| Email |
be.with.jeet@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Arunjeet KK |
| Address |
Department of Surgical gastroenterology, Aster Medcity, Kochi 682027 |
| 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 |
| Arunjeet kk |
Aster Medcity |
Department of Gastro Sciences,
Surgical Gastroenterology
Ernakulam
KERALA |
7356188222
be.with.jeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster Medcity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diversion Stoma in two arms |
Colostomy creation for diversion for rectal resections |
| Intervention |
Diversion Stoma in two arms |
Ileostomy creation for diversion for rectal resections |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with any pathology requiring rectal resections with colorectal or coloanal anastomosis
2. Patients planned to be treated by covering stoma either loop ileostomy or transverse colostomy
|
|
| ExclusionCriteria |
| Details |
1. Obstructed and Perforated tumors
2. Patients with permanent colostomy or ileostomy
3. Technical inability to perform ileostomy or colostomy, for example, previous bowel resection or anatomical factors
4. Aged less than 18 years
5. Inability of the patient to adequately cooperate.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of ileus or obstruction in immediate post operative period, due to clinically significant oedema measured using time to tolerating oral feeding and length of hospital stay. |
Occurrence of ileus or obstruction in immediate post operative period, due to clinically significant oedema measured using time to tolerating oral feeding and length of hospital stay. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Occurrence of any of the enumerated stoma related complications within 30 days from primary surgery, reported using the Comprehensive Complication Index (CCI) based on CDC
2) Occurrence of any of the enumerated stoma related complications within 30 days from stoma closure reported using CCI, given stoma closure occurred within 3 months of primary surgery
|
anytime within 30 days |
Tertiary objective:
Occurrence of Incisional Hernia after Stoma Closure within 1 year of closure surgery
|
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/01/2026 |
| 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="2"
Months="6"
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [be.with.jeet@gmail.com].
- For how long will this data be available start date provided 07-01-2026 and end date provided 07-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Diverting Loop Ileostomy versus Loop Colostomy in Rectal Resections(A Randomised Controlled trial) Primary objective: Occurrence of ileus or obstruction in immediate post operative period, due to clinically significant oedema measured using time to tolerating oral feeding and length of hospital stay. Secondary objective/s 1)Occurrence of any of the enumerated stoma related complications within 30 days from primary surgery, reported using the Comprehensive Complication Index (CCI) based on CDC. 2) Occurrence of any of the enumerated stoma related complications within 30 days from stoma closure reported using CCI, given stoma closure occurred within 3 months of primary surgery Tertiary objective: Occurrence of Incisional Hernia after Stoma Closure within 1 year of closure surgery
|