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

NCT07348146 · tracked via the Priya Life Science Egypt tracker

Sponsor

Kasr El Aini Hospital

Phase

Not applicable

Started

2025-10-30

Last updated

2026-09-22

Condition(s) studied

Metabolic SurgeryObesity & Overweight

Investigational drug(s) / intervention(s)

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

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.

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Age between 18-70 2. Patients who will undergo SADI-S surgery Exclusion Criteria: 1. Patients with severe medical conditions such as heart failure and interstitial lung disease. 2. Patients with short bowel 3. Patients with severe GERD 4. Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements 5. Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.

Primary outcome measure(s)

Intestinal Injury — One month after surgery
Anastomotic Leak Rate — one month after the surgery
Post operative Bleeding — One month after surgery
Anastomotic Stircture — Six months after surgery
Operative Time — Immediately after surgery

Trial sites (1)

Facility	City	Region	Status
Kasr Alainy Medical School, Cairo University	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07348146 on ClinicalTrials.gov ↗ ← All trials in Egypt