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Enrolling by Invitation

NCT Number: NCT07348146

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

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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Key information

Conditions

Metabolic Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy Medical School, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-70
  • Patients who will undergo SADI-S surgery

Exclusion criteria

  • Patients with severe medical conditions such as heart failure and interstitial lung disease.
  • Patients with short bowel
  • Patients with severe GERD
  • Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements
  • Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.

Treatment and study plan

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

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 Duodena-ileal Sleeve

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.

Primary outcomes

  1. Intestinal Injury

    Time frame: One month after surgery

  2. Anastomotic Leak Rate

    Time frame: one month after the surgery

  3. Post operative Bleeding

    Time frame: One month after surgery

  4. Anastomotic Stircture

    Time frame: Six months after surgery

  5. Operative Time

    Time frame: Immediately after surgery

Secondary outcomes

  1. Weight loss

    Time frame: Six months after surgery

  2. Length of Hosptial Stay

    Time frame: One month after surgery

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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