Stapler showdown: which device is safer for sleeve gastrectomy?
NCT ID NCT02731079
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared two brands of surgical staplers (Covidien and Ethicon) used in sleeve gastrectomy for people with severe obesity. Researchers wanted to see if one device caused fewer complications like bleeding or leaks. The trial was terminated early and enrolled 62 adults, so the findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sleeve gastrectomy with either Covidien or Ethicon powered stapler
- What this could lead to
- If one stapler proves better, it could guide surgeons to choose the best device for safer weight-loss surgery.
- What could go wrong
- The study was terminated early with only 62 participants, so results may not be reliable or apply to all patients.
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.
- Started
-
Jan 2018
- Finished
-
Dec 2020
- Lead sponsor
-
A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- 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 Hide 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: 1. Informed consent obtained and signed from each subject 2. Age ≥ 18 years 3. Requirement for agreement to avoid conception 4. BMI \>40 5. BMI \>35 with obesity-related co-morbidity 6. Pre-operative psychiatric evaluation 7. Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity 8. Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy Exclusion Criteria: 1. Pregnancy- Patients are not eligible for bariatric surgery, and if they become pregnant after surgery, they would present confounding variables and alter weight loss 2. Tobacco use within one month of surgery or any time within study period- Most staff will not perform bariatric surgery on active smokers as it negatively impacts healing 3. Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications 4. Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results 5. Active duty military- Not eligible for bariatric surgery
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
William Beaumont Army Medical Center
El Paso, Texas, 79934, United States
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