Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
RECRUITING
Québec
Contact Information
Primary
Mélanie Nadeau, MSc
melanie.nadeau@criucpq.ulaval.ca
418-656-8711
Backup
Suzy Laroche
suzy_laroche@ssss.gouv.qc.ca
418-656-8711
Time Frame
Start Date: 2023-02-03
Estimated Completion Date: 2027-03
Participants
Target number of participants: 151
Treatments
Active_comparator: 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)
Experimental: 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)
Sponsors
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Leads: Laval University

This content was sourced from clinicaltrials.gov