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

NCT07348146 | Enrolling By Invitation

• 1 other identifier: Stapled SADIs 082025
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metabolic Surgery; Obesity & Overweight

Keywords

Stapled versus Hand-sewn Technique; SADI-s; Metabolic Bariatric Surgery

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Weight loss

  Six months after surgery

• Length of Hosptial Stay

  One month after surgery

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

Procedure: Stapled Single Anastomosis Duodena-ileal Sleeve

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Medical School, Cairo University

Cairo, Egypt

Location

Related Publications (6)

• Kshirsagar VV, Mp H. A Comparative Study of Hand-Sewn and Stapled Anastomosis in Gastrointestinal Surgeries. Cureus. 2024 Oct 11;16(10):e71264. doi: 10.7759/cureus.71264. eCollection 2024 Oct.

  PMID: 39525136 BACKGROUND

• Ebinuma S, Kunisawa S, Fushimi K, Ichikawa N, Yoshida T, Homma S, Taketomi A, Imanaka Y. Comparative retrospective study on surgical outcomes of hand-sewn anastomosis versus stapling anastomosis for colectomy using a nationwide inpatient database in Japan with propensity score matching. Ann Gastroenterol Surg. 2024 Oct 11;9(2):379-388. doi: 10.1002/ags3.12870. eCollection 2025 Mar.

  PMID: 40046528 BACKGROUND

• Pennestri F, Sessa L, Prioli F, Salvi G, Gallucci P, Ciccoritti L, Greco F, De Crea C, Raffaelli M. Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. Langenbecks Arch Surg. 2022 Aug;407(5):1851-1862. doi: 10.1007/s00423-022-02501-z. Epub 2022 Mar 29.

  PMID: 35352174 BACKGROUND

• O'Brien PE, Hindle A, Brennan L, Skinner S, Burton P, Smith A, Crosthwaite G, Brown W. Long-Term Outcomes After Bariatric Surgery: a Systematic Review and Meta-analysis of Weight Loss at 10 or More Years for All Bariatric Procedures and a Single-Centre Review of 20-Year Outcomes After Adjustable Gastric Banding. Obes Surg. 2019 Jan;29(1):3-14. doi: 10.1007/s11695-018-3525-0.

  PMID: 30293134 BACKGROUND

• Lazzati A, Bechet S, Jouma S, Paolino L, Jung C. Revision surgery after sleeve gastrectomy: a nationwide study with 10 years of follow-up. Surg Obes Relat Dis. 2020 Oct;16(10):1497-1504. doi: 10.1016/j.soard.2020.05.021. Epub 2020 May 29.

  PMID: 32636173 BACKGROUND

• Aleassa EM, Hassan M, Hayes K, Brethauer SA, Schauer PR, Aminian A. Effect of revisional bariatric surgery on type 2 diabetes mellitus. Surg Endosc. 2019 Aug;33(8):2642-2648. doi: 10.1007/s00464-018-6541-1. Epub 2018 Oct 19.

  PMID: 30341657 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of General and Laparoscopic Surgery

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: October 30, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

EG (1)