A CLINICAL TRIAL COMPARING EARLY POST OPERATIVE COMPLICATIONS USING TWO OPERATIVE TECHNIQUES WHILE CONSTRUCTING A LOOP COLOSTOMY

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING EARLY POST OPERATIVE COMPLICATIONS IN PATIENTS UNDERGOING LOOP COLOSTOMY WITH AND WITHOUT A ROD - COLO-ROD- 0

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/09/002949

Enrollment

156

Registered

2012-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Loop colostomy operations

Interventions

Intervention1: LOOP COLOSTOMY OPERATIONS DONE WITHOUT A STOMA ROD: IN THE INTERVENTION ARM, LOOP COLOSTOMY OPERATIONS WILL BE DONE WITHOUT A STOMA ROD. Control Intervention1: LOOP COLOSTOMY OPERATION

Eligibility

Inclusion criteria

Inclusion criteria: All patients who undergo a loop colostomy operation in CMC in the department of General Surgery. (This will be an intention to treat analysis.)

Exclusion criteria

Exclusion criteria: NONE

Design outcomes

Primary

Measure	Time frame
To compare the retraction rates of stomas created by both the operative techniques.Timepoint: At three points 1. During the hospital stay. 2. On the 8th Post operative day in The outpatient clinic. 3. On the 30th Post operative day- telephonic follow up.	—

Secondary

Measure	Time frame
The following data will also be compared 1. Bleeding from the stoma and around the stoma. 2. Mucocutaneous separation of the stoma from the skin edge. 3. Stomal or parastomal abscesses. 4. Stomal necrosis. 5. Stomal oedema. 6. Skin necrosis. 7. Time to functioning of the stoma. 8. Faecal leakage which could be attributed to difficulty in stoma bag application. 9. Efficacy of faecal diversion Timepoint: At three points 1. During the hospital stay. 2. On the 8th Post operative day in The outpatient clinic. 3. On the 30th Post operative day- telephonic follow up.	—

Measure

Time frame

The following data will also be compared 1. Bleeding from the stoma and around the stoma. 2. Mucocutaneous separation of the stoma from the skin edge. 3. Stomal or parastomal abscesses. 4. Stomal necrosis. 5. Stomal oedema. 6. Skin necrosis. 7. Time to functioning of the stoma. 8. Faecal leakage which could be attributed to difficulty in stoma bag application. 9. Efficacy of faecal diversion Timepoint: At three points 1. During the hospital stay. 2. On the 8th Post operative day in The outpatient clinic. 3. On the 30th Post operative day- telephonic follow up.

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Countries

India

Contacts

Public ContactJoshua Franklyn

Christian Medical College Vellore

benjamin@cmcvellore.ac.in04162282519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026