Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

February 7, 2022 updated by: Laurent Biertho, Laval University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Procedure: Standard duodenal switch
Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
Other Names:
  • BPD-DS
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)
Procedure: Single-anastomosis duodenal switch
Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)
Other Names:
  • SADI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excess weight loss
Time Frame: 12 month
Percentage of excess weight loss mobilized in response to surgery
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peroperative complications
Time Frame: from baseline up to 60 months
Complications graded with Clavien classification
from baseline up to 60 months
Risk of malnutrition
Time Frame: from baseline to 60 months
Risk of malnutrition assessed through measurement of its risk being mild (albumin<35g\L), moderate (albumin<30g/L) or severe (albumin<25g/L)
from baseline to 60 months
Change in quality of life (SF-36)
Time Frame: from baseline to 60 months
36-item short form survey evaluating quality of life on a scale form 0 to 100
from baseline to 60 months
Change in quality of life (BAROS)
Time Frame: from baseline to 60 months
Bariatric Analyses and Reporting Outcomes System score form -7 to 9
from baseline to 60 months
Change in quality of life (QLaval)
Time Frame: from baseline to 60 months
Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7
from baseline to 60 months
Gastro-intestinal side effects
Time Frame: from baseline to 60 months
Evaluation of gastro-intestinal side effects with the Gastro-Intestinal Quality of Life Index from 0 to 144
from baseline to 60 months
Change in nutritional status (calcium)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of calcium (mmol/L)
from baseline to 60 months
Change in nutritional status (ferritin)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of ferritin (ug/L)
from baseline to 60 months
Change in nutritional status (TIBC)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of TIBC (umol/L)
from baseline to 60 months
Change in nutritional status (iron)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of iron (umol/L)
from baseline to 60 months
Change in nutritional status (prealbumin)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of prealbumin (g/L)
from baseline to 60 months
Change in nutritional status (transferrin)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis transferrin (g/L)
from baseline to 60 months
Change in nutritional status (vitamin A)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of vitamin A (umol/L)
from baseline to 60 months
Change in nutritional status (vitamin D3)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis of vitamin D3 (nmol/L)
from baseline to 60 months
Change in nutritional status (parathormone)
Time Frame: from baseline to 60 months
Change in nutritional status based on blood analysis parathormone (ng/L)
from baseline to 60 months
Change in food intake
Time Frame: from baseline to 60 months
Evaluation of the change in food intake using a web-based food frequency questionnaire (kcal/day)
from baseline to 60 months
Change in eating behavior
Time Frame: from baseline to 60 months
Change of eating behavior using the Three-Factor Eating Questionnaire evaluating cognitive restraint of eating on a scale from 0 to 20, disinhibition on a scale from 0 to 16 and hunger on a scale from 0 to 15
from baseline to 60 months
Change in food addiction
Time Frame: from baseline to 60 months
Change of eating behavior using the Yale Food Addiction Scale that includes a "symptom count" scale from 0 to 7 reflecting the number of addiction-like criteria endorsed and a dichotomous evaluation that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met
from baseline to 60 months
Change in binge eating behavior
Time Frame: from baseline to 60 months
Change of eating behavior using the Binge Eating scale from 0 to 46
from baseline to 60 months
Evolution of obesity related diseases
Time Frame: from baseline to 60 months
Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting
from baseline to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

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

Investigators

  • Principal Investigator: Laurent Biertho, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2027

Study Completion (ANTICIPATED)

March 1, 2027

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (ACTUAL)

February 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Second stage SADI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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