Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

NCT05242835 | Recruiting DMC

• 1 other identifier: Second stage SADI
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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

Keywords

Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Excess weight loss

  Percentage of excess weight loss mobilized in response to surgery

  12 month

Secondary Outcomes (20)

• Peroperative complications

  from baseline up to 60 months

• Risk of malnutrition

  from baseline to 60 months

• Change in quality of life (SF-36)

  from baseline to 60 months

• Change in quality of life (BAROS)

  from baseline to 60 months

• Change in quality of life (QLaval)

  from baseline to 60 months

Study Arms (2)

biliopancreatic diversion with duodenal switch

ACTIVE COMPARATOR

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

Procedure: Standard duodenal switch

Single-anastomosis duodeno-ileal anastomosis

EXPERIMENTAL

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

Procedure: Single-anastomosis duodenal switch

Interventions

Standard duodenal switch PROCEDURE

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

Also known as: BPD-DS

biliopancreatic diversion with duodenal switch

Single-anastomosis duodenal switch PROCEDURE

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

Also known as: SADI

Single-anastomosis duodeno-ileal anastomosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurent Biertho, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie Nadeau, MSc

CONTACT

418-656-8711; melanie.nadeau@criucpq.ulaval.ca

Suzy Laroche

CONTACT

418-656-8711; suzy_laroche@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 16, 2022
• Study Start: February 3, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CA (1)