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

Kasr El Aini Hospital

Status: Invitation-only

Conditions: Obesity & Overweight; Metabolic Surgery

Treatments: Procedure: Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S); Procedure: Stapled Single Anastomosis Duodena-ileal Sleeve

Study type: Interventional

Funder types: Other

Identifiers

NCT07348146

Stapled SADIs 082025

Details and patient eligibility

About

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).

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

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

Active Comparator group

Treatment:

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

Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)

Active Comparator group

Treatment:

Procedure: Stapled Single Anastomosis Duodena-ileal Sleeve