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Completed
NCT05753709
Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study
Conditions: Stoma Ileostomy, Stoma Colostomy, Anastomosis, Ileus, Leak, Anastomotic, Bowel Obstruction
Sex: All
Phase: NA
Enrollment: 38
Sponsor: Sawai Mansingh Medical College
Location: India
Summary
The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis).
The main question it aims to answer is:• If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity.Participants admitted for stoma reversal will be divided into two groups:EE: Conventional Hand-sewn end-to-end anastomosis, andSS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:HSSA: Hand-sewn side-to-side anastomosisSSSA: Stapled side-to-side anastomosisResearchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see:Rates of major post-operative complicationsRates of short-term complications (within 30 days of surgery)Rates of re-operationPost-operative length of stay in the hospital
Eligibility Criteria
Inclusion Criteria:Eligible participants were all the patients admitted in general surgical wards of SMS Hospital, Jaipur, for stoma reversal, after taking written informed consentExclusion Criteria:Pre-operatively diagnosed malnutrition or cachexiaBleeding disordersPatients undergoing stoma reversal along with a concurrent abdominal surgeryRectal anastomosisUse of circular stapler for anastomosis.
Source: ClinicalTrials.gov (NCT05753709). StuddyBuddy aggregates publicly available trial information.