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NCT06789965: BYPSADIS

Comparison of Two Surgical Techniques for Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodenoileal Bypass With Sleeve Gastrectomy and Roux-en-Y Gastric Bypass.

Recruiting now NA Last updated 4 May 2025
What this trial tests

NA trial testing SADI-S in Obesity in 450 participants. Currently enrolling.

Timeline
1 February 2025
Primary endpoint
1 August 2026
1 August 2030

Quick facts

Lead sponsorHospital Clinic of Barcelona
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment450
Start date1 February 2025
Primary completion1 August 2026
Estimated completion1 August 2030
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Clinic of Barcelona

Who can join

Adults 18 to 60, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Roux-en-Y gastric bypass (RY-GBP) is one of the surgical techniques most widely used for the treatment of obesity. Long series of operated patients published in the literature have demonstrated its safety and efficacy. It consists on the reduction of the size of the stomach and joining it (anastomosis) with the small bowel to reduce the absorption of calories. Single anastomosis duodenoileal with sleeve gastrectomy is an increasingly used surgical technique that is a simplification of the duodenal switch. It consists on the reduction of the stomach to a tube (sleeve gastrectomy) and an anastomosis between the duodenum and the small bowel. It has been demonstrated as a effective technique and it is supported by the international scientific societies. There are no data that indicate a superiority of one technique over the other. The objective of this study is to analyze if there are differences between the two techniques in terms of postoperative weight control and gastroesophageal reflux at short, medium and long term.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomized open-label multicentre clinical trial comparing single-anastomosis duodenal switch (SADI-S) versus Roux-en-Y gastric bypass for the treatment of severe obesity: BYPSADIS study protocol.
    Osorio J, Lazzara C, Guimaraes M, Torres A, et al · · 2026 · PMID 41104829 · DOI 10.1177/14574969251385873

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Other trials of SADI-S

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Hospital Clinic of Barcelona trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06789965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing