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ENROLLING BY INVITATION
NCT07348146
NA

Hand-Sewn vs. Stapled Anastomosis in SADI-S: Early Postoperative Complications.

Sponsor: Kasr El Aini Hospital

View on ClinicalTrials.gov

Summary

This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II).

Official title: Hand-Sewn vs. Stapled Anastomosis in SADI-S: A Prospective Randomized Trial of Early Postoperative Complications.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2025-10-30

Completion Date

2026-07-15

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

PROCEDURE

Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)

Arm 1 - Hand-sewn Duodeno-Ileal Anastomosis Following sleeve gastrectomy, a hand-sewn duodeno-ileal anastomosis is performed in two layers, with the inner layer constructed using absorbable barbed sutures and the outer reinforcing layer using absorbable monofilament sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.

PROCEDURE

Stapled Single Anastomosis Duodena-ileal Sleeve

Arm 2 - Stapled Single Anastomosis Duodena-ileal Sleeve Following sleeve gastrectomy, a stapled duodeno-ileal anastomosis is created using endoscopic linear stapling devices, followed by closure of the enterotomy in a single layer using absorbable barbed sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.

Locations (1)

Kasr Alainy Medical School, Cairo University

Cairo, Egypt