Clinical trial NCT05242835: Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
Official title: Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Obesity, Morbid
Keywords: Bariatric surgery
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
First posted: 2022-02-16
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Excess weight loss
timeFrame: 12 month
Secondary outcomes:
measure: Peroperative complications
timeFrame: from baseline up to 60 months
measure: Risk of malnutrition
timeFrame: from baseline to 60 months
measure: Change in quality of life (SF-36)
timeFrame: from baseline to 60 months
measure: Change in quality of life (BAROS)
timeFrame: from baseline to 60 months
measure: Change in quality of life (QLaval)
timeFrame: from baseline to 60 months
measure: Gastro-intestinal side effects
timeFrame: from baseline to 60 months
measure: Change in nutritional status (calcium)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (ferritin)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (TIBC)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (iron)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (prealbumin)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (transferrin)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (vitamin A)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (vitamin D3)
timeFrame: from baseline to 60 months
measure: Change in nutritional status (parathormone)
timeFrame: from baseline to 60 months
measure: Change in food intake
timeFrame: from baseline to 60 months
measure: Change in eating behavior
timeFrame: from baseline to 60 months
measure: Change in food addiction
timeFrame: from baseline to 60 months
measure: Change in binge eating behavior
timeFrame: from baseline to 60 months
measure: Evolution of obesity related diseases
timeFrame: from baseline to 60 months
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Laurent Biertho, MD
role: PRINCIPAL_INVESTIGATOR
References: