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New surgery may offer safer weight loss for the severely obese

NCT ID NCT02792166

Disease control Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a newer weight-loss surgery called SADI-S to an older, more complex one called BPD-DS in 62 adults with severe obesity. The goal is to see if SADI-S is safer and just as effective for long-term weight loss and managing related health problems like diabetes. Researchers will track complications, weight changes, and side effects over five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SADI-S (a type of weight-loss surgery that combines stomach reduction with intestinal bypass)
What this could lead to
If successful, SADI-S could offer a safer, simpler surgical option for lasting weight loss and control of obesity-related conditions like diabetes.
What could go wrong
This is a small, single-center study comparing two surgeries, so results may not apply broadly. Both procedures carry risks like malnutrition, bowel issues, and surgical complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Start date

Jun 2016

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: 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: * 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 * 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)

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Conditions

The condition(s) this trial relates to.

metabolic syndrome X morbid obesity Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Morbid obesity Obesity

Contacts and locations

Locations

  • McGill University Health Center

    Montreal, Quebec, H3G 1A4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.