Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

NCT ID: NCT05242835

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2027-03-31

Brief Summary

Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.

Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.

With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.

Conditions

Obesity; Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

biliopancreatic diversion with duodenal switch

Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

Group Type: ACTIVE_COMPARATOR

Standard duodenal switch

Intervention Type: PROCEDURE

Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

Single-anastomosis duodeno-ileal anastomosis

Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Group Type: EXPERIMENTAL

Single-anastomosis duodenal switch

Intervention Type: PROCEDURE

Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Interventions

Standard duodenal switch

Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

Intervention Type: PROCEDURE

Single-anastomosis duodenal switch

Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Intervention Type: PROCEDURE

Other Intervention Names

BPD-DS; SADI

Eligibility Criteria

Inclusion Criteria

• had sleeve gastrectomy a minimum of 18 months before
• still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL<50% or significant weight regain (≥20%EWL)

Exclusion Criteria

• general contra-indication for bariatric surgery
• BMI<35kg/m2
• pregnancy
• cirrhosis
• abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Laurent Biertho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurent Biertho, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mélanie Nadeau, MSc

Role: CONTACT

melanie.nadeau@criucpq.ulaval.ca

418-656-8711 ext. 3490

Suzy Laroche

Role: CONTACT

suzy_laroche@ssss.gouv.qc.ca

418-656-8711 ext. 3841

Facility Contacts

Suzy Laroche

Role: primary

suzy_laroche@ssss.gouv.qc.ca

418-656-8711 ext. 3841

Other Identifiers

Second stage SADI

Identifier Type: -

Identifier Source: org_study_id