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

January 17, 2026 updated by: Ahmed Abdelsalam M, Kasr El Aini Hospital

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr Alainy Medical School, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)
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.
Active Comparator: Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: Six months after surgery
Six months after surgery
Length of Hosptial Stay
Time Frame: One month after surgery
One month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stapled SADIs 082025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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