SADI-S vs. BPD-DS Surgery for Obesity

Overseen By Amin Andalib, MD MSc FRCSC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Congestive heart failure, Chronic kidney disease, Inflammatory bowel disease, Pulmonary hypertension, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a) those that cause restriction, and b) those that add a malabsorptive component to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most frequently performed procedure in North America. Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS procedure has been shown to be significantly more effective than RYGB in achieving durable weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes, the performance of BPD-DS is highly institution dependant and comprises less than 5% of the annual bariatric procedures performed worldwide. Common reservations against BPD-DS are related to the side effects of the procedure, and include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition. Furthermore, longer operative times and surgical technical challenges are also reasons for lower prevalence of the BPD-DS procedure. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is a suitable second-stage or salvage procedure for severely obese patients with inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite showing excellent results of up to 5 years with acceptable postoperative morbidity, all the literature on SADI-S originates from a single center and has not been compared directly with BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients. This project has three specific aims: 1. To evaluate feasibility and short-term safety of SADI-S. 2. To evaluate short and long-term beneficial outcomes. 3. To evaluate and compare long-term morbidity.

Research Team

Amin Andalib, MD MSc FRCSC

Principal Investigator

McGill University

Eligibility Criteria

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.

Inclusion Criteria

Participants must meet ALL of the following inclusion criteria:

I meet the NIH criteria for weight-loss surgery.

Give written informed consent

Exclusion Criteria

Individuals who were found by any member of the multidisciplinary team (nutritionist, nurse, psychologist, and surgeon) to be at risk for lack of support and poor compliance (e.g. ≥2 missed appointments without a valid justification)

Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:

I have CHF, CKD stage 3-5, IBD, PHTN, cirrhosis, or severe GERD possibly with Barrett's disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Short-term Safety Assessment

Participants undergo the SADI-S or BPD-DS procedure and are monitored for short-term safety, including operative parameters and 30-day postoperative adverse events.

4 weeks

Follow-up

Participants are monitored for weight loss, resolution of type-2 diabetes, quality of life, and long-term morbidities at 1, 6, 12 months and yearly thereafter.

5 years

Treatment Details

Interventions

• BPD-DS
• SADI-S

Trial Overview 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.

Participant Groups

Group I: SADI-S Experimental Treatment 1 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-DS Active Control 1 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).

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+