Comparing outcomes of sleeve gastrectomy using different staplers
Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices
NA · William Beaumont Army Medical Center · NCT02731079
This study is testing whether using different staplers during sleeve gastrectomy helps patients have better results after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | William Beaumont Army Medical Center (fed) |
| Locations | 1 site (El Paso, Texas) |
| Trial ID | NCT02731079 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of sleeve gastrectomy performed with two different stapling devices, Covidien and Ethicon. Patients who are undergoing this common bariatric surgery will be randomly assigned to one of the two devices, and various intraoperative and postoperative metrics will be recorded. These metrics include time to create the sleeve, intraoperative bleeding, complications requiring readmission, and weight loss outcomes. The goal is to determine if one device leads to better clinical outcomes than the other, beyond just cost considerations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI over 40 or over 35 with obesity-related comorbidities who are undergoing sleeve gastrectomy.
Not a fit: Patients who are pregnant, active smokers, or have a history of prior bariatric surgery or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the stapler that provides better surgical outcomes, potentially reducing complications and improving weight loss for patients.
How similar studies have performed: While many studies have evaluated various aspects of sleeve gastrectomy, this specific comparison of stapler devices is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
El Paso, Texas
- William Beaumont Army Medical Center — El Paso, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Eric P Ahnfeldt, DO — Residency Program Director
- Study coordinator: Chelsey A McKinnon, MD
- Email: chelsey.a.mckinnon.mil@mail.mil
- Phone: 915 742 2282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Morbid Obesity, Sleeve gastrectomy stapler Covidien Ethicon bleeding leak