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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Short-term Safety Assessment

Weight loss

Secondary study objectives

Long-term Morbidity Assessment

Quality of Life Assessment

Remission of T2DM

+1 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: 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).

0 / 3Eligibility criteria met