Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery. However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins. Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique. The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
RECRUITINGExcess weight loss
Excess weight loss at 2 years of follow-up %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values
Time frame: 2 years
Rate of protein deficiency or insufficiency
Rate of protein deficiency (\<35gr/l) or insufficiency (\<30gr/l)
Time frame: from baseline up to 60 months
Mortality rate
Rate of mortality
Time frame: from baseline up to 60 months
BMI
change in BMI at 2 years follow-up as compared to preoperative reference values
Time frame: 2 years
Complication rate
overall and surgery-specific complications
Time frame: from baseline up to 60 months
Cure rate of comorbidities
Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea
Time frame: from baseline up to 60 months
Rate of minerals and vitamin deficiencies
Rate of deficiency and insufficiency in mineral and vitamins
Time frame: from baseline up to 60 months
Body composition by bioimpedance measures
body fat composition (%) assessed by biompedance
Time frame: from baseline up to 60 months
Change in quality of life
36-item short form survey score from 0 to 100
Time frame: from baseline up to 60 months
Change in quality of life
Bariatric Analysis and Reporting Outcomes System score from -7 to 9
Time frame: from baseline up to 60 months
Change in quality of life
Laval Questionnaire score from 0 to 7
Time frame: from baseline up to 60 months
Change in quality of life
GastroIntestinal Quality of Life Index from 0 to 144
Time frame: from baseline up to 60 months
Change in gatroesophageal reflux symptom
GastroEsophageal Reflus Disease Score from 0 to 72
Time frame: from baseline to 60 months
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