Obesity, Obesity, Morbid
Conditions
Keywords
Bariatric surgery
Brief summary
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.
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
Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a single-center double-blind randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who had a parietal gastrectomy more than 18 months ago and * Who still meet NIH criteria for bariatric surgery (BMI ≥ 35kg/m2 with associated disease or BMI ≥ 40kg/m2) or * Have lost \< 50% of their excess weight, or * Have significant weight regain (≥ 20% EWL) * Accepting long-term care and follow-up and willing to participate in this study after informed consent
Exclusion criteria
* Other bariatric procedures apart from parietal gastrectomy. * Psychiatric illness not stabilized for more than 6 months * Severe illness with life-threatening consequences within 5 years * Diagnosis of cancer within the last 3 years * Chronic digestive disorders (chronic diarrhea, inflammatory diseases, cirrhosis, intestinal resections, functional abdominal pain) * Pregnancy or desire for pregnancy within 2 years * Intellectual retardation making consent impossible or patient under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | from baseline to 60 months | % Excess weights loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early complications | from baseline to 30 days | Complication (≤30 days) graded with Clavien classification |
| Late complications | from 30 days to 60 months | Complication (\>30 days to 60 months) ga=raded with Clavien classification |
| Operating time | baseline | Operating time in minutes |
| Blood loss | baseline | Peroperative blood loss (ml) as reported in the operating room |
| Hospital stay | baseline | length of hospital stay (days) |
| Change in quality of life (QLaval) | from baseline to 60 months | 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 |
| Mortality rate | from baseline to 60 months | Mortality rate |
| Digestive side effects (GERD) | from baseline to 60 months | Evaluation of gastro-oesophageal reflux symptoms using the GERD Score questionnaire, on a scale from 0 to 72, higher scores indicating greater symptoms |
| Digestive side effects (LARS) | baseline to 60 months | Evaluation of bowel function using the LARS questionnaire, on a scale from 0 to 42, with higher scores indicating greater symptoms |
| Digestive side effect (GIQLI) | from baseline to 60 months | 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 |
| Malnutrition rate | from baseline to 60 months | Malnutrition rate using albuminemia (mild 30-34.9g/L; moderate 25-29.9g/L; severe \<25g/L) |
| Nutrient deficiency rate | from baseline to 60 months | 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 |
| Resolution of associated comorbidities | from baseline to 60 months | 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. |
| Change in quality of life (SF36) | from baseline to 60 months | 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 |
Countries
Canada
Outcome results
None listed