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| Name | Class |
|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biliopancreatic diversion with duodenal switch | Active Comparator | Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb) |
|
| Single-anastomosis duodeno-ileal anastomosis | Experimental | Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard duodenal switch | Procedure | Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excess weight loss | Percentage of excess weight loss mobilized in response to surgery | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Peroperative complications | Complications graded with Clavien classification | from baseline up to 60 months |
| Risk of malnutrition | Risk of malnutrition assessed through measurement of its risk being mild (albumin<35g\L), moderate (albumin<30g/L) or severe (albumin<25g/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MĂ©lanie Nadeau, MSc | Contact | 418-656-8711 | 3490 | melanie.nadeau@criucpq.ulaval.ca |
| Suzy Laroche | Contact | 418-656-8711 | 3841 | suzy_laroche@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Biertho, MD | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Single-anastomosis duodenal switch | Procedure | Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel) |
|
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| from baseline to 60 months |
| Change in quality of life (SF-36) | 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) | Bariatric Analyses and Reporting Outcomes System score form -7 to 9 | from baseline to 60 months |
| Change in quality of life (QLaval) | 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 | 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) | Change in nutritional status based on blood analysis of calcium (mmol/L) | from baseline to 60 months |
| Change in nutritional status (ferritin) | Change in nutritional status based on blood analysis of ferritin (ug/L) | from baseline to 60 months |
| Change in nutritional status (TIBC) | Change in nutritional status based on blood analysis of TIBC (umol/L) | from baseline to 60 months |
| Change in nutritional status (iron) | Change in nutritional status based on blood analysis of iron (umol/L) | from baseline to 60 months |
| Change in nutritional status (prealbumin) | Change in nutritional status based on blood analysis of prealbumin (g/L) | from baseline to 60 months |
| Change in nutritional status (transferrin) | Change in nutritional status based on blood analysis transferrin (g/L) | from baseline to 60 months |
| Change in nutritional status (vitamin A) | Change in nutritional status based on blood analysis of vitamin A (umol/L) | from baseline to 60 months |
| Change in nutritional status (vitamin D3) | Change in nutritional status based on blood analysis of vitamin D3 (nmol/L) | from baseline to 60 months |
| Change in nutritional status (parathormone) | Change in nutritional status based on blood analysis parathormone (ng/L) | from baseline to 60 months |
| Change in food intake | 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 | 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 | 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 | Change of eating behavior using the Binge Eating scale from 0 to 46 | from baseline to 60 months |
| Evolution of obesity related diseases | Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting | from baseline to 60 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |