NCT07348146

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metabolic Surgery
• Obesity & Overweight

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-05-01
• Completion: 2026-07-15
• First posted: 2026-01-16
• Last updated: 2026-01-21

Locations

1 site across 1 country: Egypt