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Procedure

Metabolic Surgery for Obesity

N/A

Waitlist Available

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 from baseline to 60 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Excess weight loss

Secondary outcome measures

Change in binge eating behavior

Change in eating behavior

Change in food addiction

+17 more

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER

18 Previous Clinical Trials

3,332 Total Patients Enrolled

1 Trials studying Obesity

60 Patients Enrolled for Obesity

Laval UniversityLead Sponsor

417 Previous Clinical Trials

172,121 Total Patients Enrolled

32 Trials studying Obesity

16,141 Patients Enrolled for Obesity

Institut universitaire de cardiologie et de pneumologie de QuébecUNKNOWN

3 Previous Clinical Trials

1,837 Total Patients Enrolled

Media Library

Single-anastomosis duodenal switch (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05242835 — N/A

Obesity Research Study Groups: Single-anastomosis duodeno-ileal anastomosis, biliopancreatic diversion with duodenal switch

Obesity Clinical Trial 2023: Single-anastomosis duodenal switch Highlights & Side Effects. Trial Name: NCT05242835 — N/A

Single-anastomosis duodenal switch (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05242835 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 60 or above being considered for enrollment in this trial?

"Eligibility criteria for this study requires participants to be under 60 years old and over the age of majority."

Answered by AI

May I be accepted into this research project?

"This research is looking for 151 participants with obesity between 18 and 60 years old. Eligibility necessitates that those recruited have undergone a sleeve gastrectomy at least one-and-a-half years prior, meet the National Institute of Health's bariatric surgery criteria (with either BMI ≥ 35kg/m2 combined with major comorbidities or BMI ≥ 40 kg/m2), have achieved an excess weight loss percentage lower than 50%, or experienced considerable weight regain (>20%EWL)."

Answered by AI

Is there any availability for patient enrollment into this research trial?

"According to the official records on clinicaltrials.gov, this medical trial has officially ceased recruitment as of February 7th 2022; however, there are still 1011 other studies actively seeking volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Laurent Biertho 2022. "Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05242835.

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