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| Name | Class |
|---|---|
| Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec | UNKNOWN |
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Bilio-pancreatic bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this operation.
Recently, a simplified "Duodenal Switch" technique has been proposed. This technique is known as "Single Anastomosis Duodeno-Ileal bypass" (SADI) and involves connecting the duodenum to the ileum, 250 cm upstream of the ileo-caecal valve, via an "omega" loop. This surgery is technically simpler and possibly less risky (particularly from a nutritional point of view) than the "standard" technique developed at the IUCPQ. This explains the enthusiasm in the surgical community for SADI, although the scientific evidence is very limited. The investigator has therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery.
In this study, the investigator aims to evaluate the results of SADI versus standard bypass, as 2nd-stage surgery after parietal gastrectomy.
The hypothesis is that SADI will be accompanied by fewer digestive and nutritional side effects, but also by a lower weight loss and a lower rate of recovery from comorbidities.
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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 duodenal-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 |
|---|---|---|
| Weight loss | % Excess weights loss | from baseline to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Mortality rate | from baseline to 60 months |
| Early complications | Complication (≤30 days) graded with Clavien classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Criucpq-Ul | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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This is a single-center double-blind randomized trial
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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) |
|
| from baseline to 30 days |
| Late complications | Complication (>30 days to 60 months) ga=raded with Clavien classification | from 30 days to 60 months |
| Operating time | Operating time in minutes | baseline |
| Blood loss | Peroperative blood loss (ml) as reported in the operating room | baseline |
| Hospital stay | length of hospital stay (days) | baseline |
| Change in quality of life (QLaval) | Change in quality of life assessed by the Laval questionnaire evaluating 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life | from baseline to 60 months |
| Change in quality of life (SF36) | change in quality of life assessed with the 36-item short form survey evaluating quality of life on a scale form 0 to 100, higher scores indicate better quality of life | from baseline to 60 months |
| Digestive side effects (GERD) | Evaluation of gastro-oesophageal reflux symptoms using the GERD Score questionnaire, on a scale from 0 to 72, higher scores indicating greater symptoms | from baseline to 60 months |
| Digestive side effects (LARS) | Evaluation of bowel function using the LARS questionnaire, on a scale from 0 to 42, with higher scores indicating greater symptoms | baseline to 60 months |
| Digestive side effect (GIQLI) | Evaluation of digestive side effect using the Laval digestive problems evaluation questionnaire, on a scale from 0 to 144, with higher scores indicating less negative impact of symptoms | from baseline to 60 months |
| Malnutrition rate | Malnutrition rate using albuminemia (mild 30-34.9g/L; moderate 25-29.9g/L; severe <25g/L) | from baseline to 60 months |
| Nutrient deficiency rate | Nutrient deficiency rate based on blood analysis of vitamine A, vitamin D, vitamin B12, Calcium, magnsium, phosphorus, iron, ferritin, TIBC and parathormone and the required dose of supplements | from baseline to 60 months |
| Resolution of associated comorbidities | Type 2 diabetes, hypertension, sleep apnea and dislipidemia evolution are evaluated according to treatment, symptoms, vital signs and blood test results to determine whether there has been resolution, improvement, no change, deterioration, or recurrence of the condition according to the criteria of the American Society for Metabolic & Bariatric Surgery. | from baseline to 60 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |