Obesity, Obesity, Morbid
Conditions
Keywords
Bariatric surgery
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.
Interventions
PROCEDUREStandard duodenal switch
Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
PROCEDURESingle-anastomosis duodenal switch
Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)
Sponsors
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excess weight loss | 12 month | Percentage of excess weight loss mobilized in response to surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of malnutrition | 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) |
| Change in quality of life (SF-36) | from baseline to 60 months | 36-item short form survey evaluating quality of life on a scale form 0 to 100 |
| Change in quality of life (BAROS) | from baseline to 60 months | Bariatric Analyses and Reporting Outcomes System score form -7 to 9 |
| Change in quality of life (QLaval) | from baseline to 60 months | Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7 |
| Gastro-intestinal side effects | from baseline to 60 months | Evaluation of gastro-intestinal side effects with the Gastro-Intestinal Quality of Life Index from 0 to 144 |
| Change in nutritional status (calcium) | from baseline to 60 months | Change in nutritional status based on blood analysis of calcium (mmol/L) |
| Change in nutritional status (ferritin) | from baseline to 60 months | Change in nutritional status based on blood analysis of ferritin (ug/L) |
| Change in nutritional status (TIBC) | from baseline to 60 months | Change in nutritional status based on blood analysis of TIBC (umol/L) |
| Change in nutritional status (iron) | from baseline to 60 months | Change in nutritional status based on blood analysis of iron (umol/L) |
| Peroperative complications | from baseline up to 60 months | Complications graded with Clavien classification |
| Change in nutritional status (transferrin) | from baseline to 60 months | Change in nutritional status based on blood analysis transferrin (g/L) |
| Change in nutritional status (vitamin A) | from baseline to 60 months | Change in nutritional status based on blood analysis of vitamin A (umol/L) |
| Change in nutritional status (vitamin D3) | from baseline to 60 months | Change in nutritional status based on blood analysis of vitamin D3 (nmol/L) |
| Change in nutritional status (parathormone) | from baseline to 60 months | Change in nutritional status based on blood analysis parathormone (ng/L) |
| Change in food intake | from baseline to 60 months | Evaluation of the change in food intake using a web-based food frequency questionnaire (kcal/day) |
| Change in eating behavior | 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 |
| Change in food addiction | 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 |
| Change in binge eating behavior | from baseline to 60 months | Change of eating behavior using the Binge Eating scale from 0 to 46 |
| Evolution of obesity related diseases | from baseline to 60 months | Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting |
| Change in nutritional status (prealbumin) | from baseline to 60 months | Change in nutritional status based on blood analysis of prealbumin (g/L) |
Countries
Canada
Contacts
Primary ContactMélanie Nadeau, MSc
Backup ContactSuzy Laroche
Outcome results
None listed