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COMPARISON OF MONOFILAMENT ABSORBABLE SUTURE VERSUS BRAIDED SILK SUTURE FOR SINGLE-LAYERED INTERRUPTED SMALL BOWEL STOMA REVERSAL

COMPARISON OF MONOFILAMENT ABSORBABLE SUTURE VERSUS BRAIDED SILK SUTURE FOR SINGLE-LAYERED INTERRUPTED SMALL BOWEL STOMA REVERSAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260710017
Enrollment
52
Registered
2026-07-10
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients undergoing small bowel stoma reversal (ileostomy closure) requiring intestinal anastomosis Ileostomy Intestinal Anastomosis Surgical Sutures Polydioxanone Small Intestine Surgery

Interventions

Patients randomized to Arm 1 underwent small bowel stoma reversal using single-layer interrupted extra-mucosal intestinal anastomosis with monofilament absorbable polydioxanone (PDS) 3-0 suture. Stand
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Monofilament Absorbable Polydioxanone (PDS) Suture,Braided Silk Suture

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged more than 18 years. 2. Patients undergoing small bowel stoma closure (loop or double-barrel stoma). 3. Patients willing to participate and providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing colostomy closure. 2. Patients in whom the distal loop was colon. 3. Patients undergoing stoma closure following malignancy. 4. Patients unwilling to participate or not providing informed consent.

Design outcomes

Primary

MeasureTime frame
Anastomosis Time During surgery (intraoperative) Time required to complete intestinal anastomosis measured in minutes using intraoperative timing

Secondary

MeasureTime frame
Subclinical Intestinal Obstruction Postoperative period until hospital discharge Clinical assessment for abdominal distension, bowel function, and conservative management requirement,Anastomotic Leak Postoperative period until hospital discharge Clinical assessment based on abdominal signs, wound discharge, drain output, and need for intervention,Wound Infection Postoperative period until hospital discharge Clinical examination for surgical site infection including wound discharge, erythema, or wound gaping,Enterocutaneous Fistula Postoperative period until hospital discharge Clinical detection of enteric discharge through wound or fistulous tract,Reoperation Postoperative period until hospital discharge Requirement for repeat surgical intervention related to postoperative complications,Day of Oral Allowance Postoperative period until hospital discharge Number of postoperative days to initiation of oral intake following return of bowel function,Hospital Stay At hospital discharge Duration of hospitalization measured in days from surgery to discharge

Countries

India

Contacts

Public ContactNitin Agarwal

Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital

drnitinagarwal76@gmail.com09810568719

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026