ClinicalTrials.gg
Enrolling by invitationNCT07348146Updated Sep 22, 2026

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

An interventional study of Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) and Stapled Single Anastomosis Duodena-ileal Sleeve in Metabolic Surgery and Obesity & Overweight, sponsored by Kasr El Aini Hospital. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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).

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Conditions studied

  • Metabolic Surgery
  • Obesity & Overweight

Keywords

  • Stapled versus Hand-sewn Technique
  • SADI-s
  • Metabolic Bariatric Surgery
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In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 82 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 18-70
  2. Patients who will undergo SADI-S surgery

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

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

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

  • Active comparator
    Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)

    Procedure: Stapled Single Anastomosis Duodena-ileal Sleeve

Interventions

  • ProcedureHand-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.

  • ProcedureStapled 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.

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What researchers measure

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

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 39525136 ↗
  • 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. PubMed 40046528 ↗
  • 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. PubMed 35352174 ↗
  • 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. PubMed 30293134 ↗
  • 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. PubMed 32636173 ↗
  • 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. PubMed 30341657 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07348146
Responsible party
Ahmed Abdelsalam M (Associate Professor of General and Laparoscopic Surgery, Kasr El Aini Hospital) — Principal investigator
First posted
Jan 16, 2026
Start date
Oct 30, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Sep 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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