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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2026-07-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Metabolic Surgery Obesity & Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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 Duodeno-Ileal Sleeve (SADI-S)

Group Type ACTIVE_COMPARATOR

Stapled Single Anastomosis Duodena-ileal Sleeve

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No