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Procedure

SADI-S vs. BPD-DS Surgery for Obesity

N/A
Waitlist Available
Led By Amin Andalib, MD MSc FRCSC
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years and ≤60 years
Fulfill criteria for bariatric surgery as coined by National Institutes of Health
Must not have
Presence of the following baseline comorbidities: Congestive heart failure (CHF), Chronic kidney disease (CKD) stage 3-5 (or GFR <60 ml/min per 1.73 m2), Inflammatory bowel disease (IBD), Pulmonary hypertension (PHTN), Cirrhosis, Severe gastroesophageal reflux disorder (GERD) +/- presence of any Barrett's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial is being done to see if a type of weight-loss surgery is effective and safe. The surgery is called SADI-S, and it's being compared to another type of surgery called BPD-DS.

Who is the study for?
This trial is for adults aged 18-60 who meet the criteria for bariatric surgery. They must be able to give informed consent. It's not suitable for those with poor support/compliance, heart failure, advanced kidney disease, inflammatory bowel disease, pulmonary hypertension, cirrhosis or severe GERD.Check my eligibility
What is being tested?
The study compares two weight loss surgeries in obese patients: BPD-DS and a newer version called SADI-S. The goal is to see if SADI-S is as safe and effective as BPD-DS in the short and long term.See study design
What are the potential side effects?
Potential side effects include frequent bowel movements, flatulence, malnutrition (fat, micronutrient and protein), which are common concerns with BPD-DS; these may also apply to SADI-S.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I meet the NIH criteria for weight-loss surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have CHF, CKD stage 3-5, IBD, PHTN, cirrhosis, or severe GERD possibly with Barrett's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Short-term Safety Assessment
Weight loss
Secondary outcome measures
Long-term Morbidity Assessment
Quality of Life Assessment
Remission of T2DM
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SADI-SExperimental Treatment1 Intervention
SADI-S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ileocecal valve (longer common channel) to the transected first-stage of the duodenum instead of the Roux-en-Y construct.
Group II: BPD-DSActive Control1 Intervention
BPD-DS involves creating a sleeve gastrectomy and creation of a Roux-en-Y bypass involving a Roux limb (150cm) which is anastomosed to the transected first-stage of the duodenum and a short common channel (100cm).

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
452 Previous Clinical Trials
161,852 Total Patients Enrolled
2 Trials studying Obesity
94 Patients Enrolled for Obesity
Amin Andalib, MD MSc FRCSCPrincipal InvestigatorMcGill University

Media Library

BPD-DS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02792166 — N/A
Obesity Research Study Groups: SADI-S, BPD-DS
Obesity Clinical Trial 2023: BPD-DS Highlights & Side Effects. Trial Name: NCT02792166 — N/A
BPD-DS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02792166 — N/A
~3 spots leftby Mar 2025