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Procedure

Metabolic Surgery for Obesity

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

Must not have

abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease

general contra-indication for bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the clinical effects of SADI-S vs DS in patients who need revisional surgery after SG. The primary outcome will be 12-month excess weight loss.

Who is the study for?

This trial is for individuals who had sleeve gastrectomy at least 18 months ago, still qualify for bariatric surgery based on their BMI and health conditions, or have not lost enough weight or regained a significant amount. It's not for those who are pregnant, have cirrhosis, general contraindications to bariatric surgery, abnormal bowel habits like IBS or IBD, or a BMI under 35.

What is being tested?

The study compares two surgeries for managing obesity after initial sleeve gastrectomy failure: the standard duodenal switch (DS) and the newer single-anastomosis duodenal switch (SADI-S). Participants will be randomly assigned to one of these procedures in a double-blind setup to measure which is more effective at weight loss without causing as many complications.

What are the potential side effects?

Potential side effects include perioperative complications such as infections or bleeding, risk of malnutrition due to changes in digestion and absorption of nutrients, and gastrointestinal issues like nausea or diarrhea. The SADI-S aims to reduce these compared to the standard DS.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have irregular bowel habits or a diagnosed bowel condition.

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I am not a candidate for weight loss surgery due to health risks.

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I have cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Excess weight loss

Secondary study objectives

Change in binge eating behavior

Change in eating behavior

Change in food addiction

+17 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: Single-anastomosis duodeno-ileal anastomosisExperimental Treatment1 Intervention

Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Group II: biliopancreatic diversion with duodenal switchActive Control1 Intervention

Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

0 / 3Eligibility criteria met