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Procedure

Single vs Standard Duodenal Switch for Obesity (SADI Trial)

N/A
Recruiting
Led By Laurent Biertho, MD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the new, simplified Duodenal-Switch technique to the standard BPD-DS technique.

Who is the study for?
This trial is for adults aged 18-60 who meet the criteria for bariatric surgery with a BMI≥35 and can give informed consent. It's not suitable for those with psychological issues affecting treatment compliance, recent substance abuse, gastrointestinal inflammatory diseases, severe organ disease, past stomach surgeries, Type 1 Diabetes or pregnancy.
What is being tested?
The study compares two weight loss surgeries: Single Anastomosis Duodenal Switch (a simplified technique) versus the Standard Duodenal Switch. The goal is to see which procedure offers better outcomes in terms of weight loss and diabetes remission while assessing long-term nutritional effects.
What are the potential side effects?
Potential side effects may include nutritional deficiencies due to altered food digestion and absorption. There could also be risks associated with any major surgery such as infection, bleeding, or adverse reactions to anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BMI
Excess weight loss
Mortality rate
+1 more
Secondary study objectives
Body composition by bioimpedance measures
Change in gatroesophageal reflux symptom
Change in quality of life
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SADIExperimental Treatment1 Intervention
Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel
Group II: BPD-DSActive Control1 Intervention
Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb

Find a Location

Who is running the clinical trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER
23 Previous Clinical Trials
4,193 Total Patients Enrolled
2 Trials studying Obesity
211 Patients Enrolled for Obesity
Laval UniversityLead Sponsor
434 Previous Clinical Trials
178,421 Total Patients Enrolled
33 Trials studying Obesity
16,280 Patients Enrolled for Obesity
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,615 Total Patients Enrolled
1 Trials studying Obesity
410 Patients Enrolled for Obesity
Laurent Biertho, MDPrincipal InvestigatorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval
2 Previous Clinical Trials
171 Total Patients Enrolled
1 Trials studying Obesity
151 Patients Enrolled for Obesity
~8 spots leftby Sep 2025
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