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NCT02792166Completed

Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study

Source: ClinicalTrials.gov · Last updated 1 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
62 (actual)
First submitted
2 Jun 2016
Start date
1 Jun 2016
Primary completion date
31 Dec 2019
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Diseases
Obesity
NCT number
NCT02792166

What you commit to

  • Study type: Interventional
  • Participants enrolled: 62
  • From 1 Jun 2016 to the primary completion date, 31 Dec 2019
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Congestive heart failure (CHF),
  • Inflammatory bowel disease (IBD),
  • Pulmonary hypertension (PHTN),
  • Severe gastroesophageal reflux disorder (GERD) +/- presence of any Barrett's disease

Lab values

  • Chronic kidney disease (CKD) stage 3-5 (or GFR \<60 ml/min per 1.73 m2),

Other

  • Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
  • Presence of the following baseline comorbidities:
  • Cirrhosis.
  • 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)

Who the study is looking for

  • Participants must meet ALL of the following inclusion criteria:
  • Age ≥18 years and ≤60 years
  • Fulfill criteria for bariatric surgery as coined by National Institutes of Health
  • Give written informed consent

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University Health Center
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.