A CLINICAL TRIAL COMPARING EARLY POST OPERATIVE COMPLICATIONS USING TWO OPERATIVE TECHNIQUES WHILE CONSTRUCTING A LOOP COLOSTOMY
Phase 3
- Conditions
- Health Condition 1: null- Loop colostomy operations
- Registration Number
- CTRI/2012/09/002949
- Lead Sponsor
- Fluid Research Grant CMC Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 156
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
NONE
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the retraction rates of stomas created by both the operative techniques.Timepoint: At three points <br/ ><br>1. During the hospital stay. <br/ ><br>2. On the 8th Post operative day in The outpatient clinic. <br/ ><br>3. On the 30th Post operative day- telephonic follow up.
- Secondary Outcome Measures
Name Time Method The following data will also be compared <br/ ><br> 1. Bleeding from the stoma and around the stoma. <br/ ><br> 2. Mucocutaneous separation of the stoma from the skin edge. <br/ ><br> 3. Stomal or parastomal abscesses. <br/ ><br> 4. Stomal necrosis. <br/ ><br> 5. Stomal oedema. <br/ ><br> 6. Skin necrosis. <br/ ><br> 7. Time to functioning of the stoma. <br/ ><br> 8. Faecal leakage which could be attributed to difficulty in stoma bag application. <br/ ><br> 9. Efficacy of faecal diversion <br/ ><br>Timepoint: At three points <br/ ><br>1. During the hospital stay. <br/ ><br>2. On the 8th Post operative day in The outpatient clinic. <br/ ><br>3. On the 30th Post operative day- telephonic follow up.