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Procedure

Sleeve Gastrectomy Outcomes With Different Stapling Devices

N/A
Recruiting
Led By Eric P Ahnfeldt, DO
Research Sponsored by William Beaumont Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
Awards & highlights
No Placebo-Only Group

Summary

Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this study is to compare intraoperative characteristics, such as time to create sleeve, intraoperative bleeding, and time needed to load each cartridge, and post-operative characteristics, such as any complication requiring readmission (leak or hemorrhage), further surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy with Covidien devices and Ethicon devices. Currently the investigators predominantly use whatever device is cheaper, but cost should not be the primary decisive factor if one device is superior to the other. If one device has better clinical outcomes, it should be the preferred device regardless of cost. If neither proves superiority, the investigators can justify using cost to determine which device to use in patient care.

Eligible Conditions
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Hospital readmissions or emergency room visits
Intra-operative staple line bleeding
Sleeve-related complications requiring surgery, recorded as yes or no

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: EthiconActive Control1 Intervention
Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement.
Group II: CovidienActive Control1 Intervention
Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement.

Find a Location

Who is running the clinical trial?

William Beaumont Army Medical CenterLead Sponsor
16 Previous Clinical Trials
2,196 Total Patients Enrolled
Eric P Ahnfeldt, DOPrincipal InvestigatorResidency Program Director
~19 spots leftby Dec 2025