Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Laval University

Status: Enrolling

Conditions: Obesity; Obesity, Morbid

Treatments: Procedure: Standard duodenal switch; Procedure: Single-anastomosis duodenal switch

Study type: Interventional

Funder types: Other

Identifiers

NCT05242835

Second stage SADI

Details and patient eligibility

About

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.

Enrollment: 151 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 2 patient groups

biliopancreatic diversion with duodenal switch

Active Comparator group

Description:

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

Treatment:

Procedure: Standard duodenal switch

Single-anastomosis duodeno-ileal anastomosis

Experimental group

Description:

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

Treatment:

Procedure: Single-anastomosis duodenal switch