Actively Recruiting
Single Anastomosis Versus Standard Duodenal Switch
Led by Laval University · Updated on 2024-08-09
120
Participants Needed
1
Research Sites
574 weeks
Total Duration
On this page
Sponsors
L
Laval University
Lead Sponsor
I
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Anastomosis Versus Standard Duodenal Switch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 60 years or younger
- Meet the National Institutes of Health criteria for bariatric surgery with BMI 35 or higher
- Provide written informed consent
You will not qualify if you...
- Have inflammatory bowel disease (IBD) or cirrhosis
- History of gastric or duodenal ulcers
- Low albumin levels before surgery (less than 35 g/L)
- Serious kidney, liver, heart, or lung disease
- Previous esophageal, gastric, or bariatric surgery
- Have Type 1 Diabetes
- Currently pregnant
- Psychological problems affecting understanding or following medical advice
- Drug use or alcohol abuse in the last 6 months
- History of gastrointestinal inflammatory diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
S
Suzy Laroche
CONTACT
M
Mélanie Nadeau, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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