Enrolling by invitation NCT07348146
Hand-Sewn vs. Stapled Anastomosis in SADI-S: Early Postoperative Complications.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S), Stapled Single Anastomosis Duodena-ileal Sleeve.
- Who it may be relevant to
- Registry conditions: Metabolic Surgery, Obesity & Overweight. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hand-Sewn vs. Stapled Anastomosis in SADI-S: A Prospective Randomized Trial of Early Postoperative Complications.
Overview
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).
Interventions
- 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. - 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.
Primary outcome measures
- Intestinal Injury [Time frame: One month after surgery]
- Anastomotic Leak Rate [Time frame: one month after the surgery]
- Post operative Bleeding [Time frame: One month after surgery]
- Anastomotic Stircture [Time frame: Six months after surgery]
- Operative Time [Time frame: Immediately after surgery]
Secondary outcome measures (2)
- Weight loss [Time frame: Six months after surgery]
- Length of Hosptial Stay [Time frame: One month after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kasr Alainy Medical School, Cairo University — Cairo
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 30341657
Identifiers
NCT: NCT07348146 · Stapled SADIs 082025