Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Informed consent obtained and signed from each subject

• Age ≥ 18 years

• Requirement for agreement to avoid conception

• BMI \>40

• BMI \>35 with obesity-related co-morbidity

• Pre-operative psychiatric evaluation

• Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity

• Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy

Locations
United States
Texas
William Beaumont Army Medical Center
RECRUITING
El Paso
Contact Information
Primary
Chelsey A McKinnon, MD
chelsey.a.mckinnon.mil@mail.mil
915 742 2282
Backup
Daniel J Roubik, MD
daniel.j.roubik.mil@mail.mil
915-742-2282
Time Frame
Start Date: 2018-01-22
Estimated Completion Date: 2021-03
Participants
Target number of participants: 150
Treatments
Active_comparator: Covidien
Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement.
Active_comparator: Ethicon
Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement.
Related Therapeutic Areas
Sponsors
Leads: William Beaumont Army Medical Center

This content was sourced from clinicaltrials.gov