EARLY VERSUS CONVENTIONAL STOMA CLOSURE FOLLOWING BOWEL SURGERY- A RANDOMISED CONTROLLED TRIAL
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Recruiting
- Sponsor
- JIPMER
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- TO DETERMINE THE FREQUENCY OF COMPLICATIONS IN THE EARLY AND CONVENTIONAL STOMA CLOSURE GROUP FOLLOWING BOWEL SURGERY.
Study Overview
Brief Summary
All patients who underwent temporary stoma following bowel surgeries will be included in the randomised study from 2013-2015 after getting informed consent. Early stoma closure is done within 28 days following index operation whereas conventional stoma closure ranges from 8-12 weeks. Preoperatively patient’s quality of life will be assessed by modified health questionnaire of European Organisation for Research and Treatment of Cancer(EORTC) . Intraoperative complications like bleeding, laparotomy and postoperative complications like wound infection, anastomotic leak, intra abdominal abscess will be assessed between the two groups. Stratification of complications is done by Clavien-Dindo classification. Cost pertaining to stoma care and length of hospital stay will be analysed between the groups. Assessment for frequency of complications and quality of life would be done by 4 weeks at 1st follow-up and 12 weeks at 2nd followup after stoma closure.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ALL CONSECUTIVE PATIENTS UNDERGOING TEMPORARY STOMA FOLLOWING BOWEL SURGERIES.
Exclusion Criteria
- •1.EMERGENCY STOMA REVISION
- •LAPAROSCOPIC BOWEL SURGERIES
- •SIGNS OF ACTIVE INFECTION OR ORGAN FAILURE IN POSTOPERATIVE PERIOD.
- •RADIOLOGICAL SIGNS OF ANASTOMOTIC LEAKAGE EVIDENT AT WATER SOLUBLE CONTRAST EXAMINATION BEFORE STOMA CLOSURE.
- •5.MALNOURISHED PATIENTS.
Outcomes
Primary Outcomes
TO DETERMINE THE FREQUENCY OF COMPLICATIONS IN THE EARLY AND CONVENTIONAL STOMA CLOSURE GROUP FOLLOWING BOWEL SURGERY.
Time Frame: INTRAOPERATIVE AND POSTOPERATIVE PERIOD,4 WEEKS AND 12 WEEKS AFTER STOMA CLOSURE.
Secondary Outcomes
- TO ASSESS THE HEALTH RELATED QUALITY OF LIFE AND ANALYSE THE COST TOWARDS STOMA CARE(BEFORE AND AFTER STOMA CLOSURE)