Sleeve Gastrectomy Outcomes With Different Stapling Devices

Description

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.

Conditions

Morbid Obesity

Study Overview

Study Details

Study overview

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.

Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices

Sleeve Gastrectomy Outcomes With Different Stapling Devices

Condition
Morbid Obesity
Intervention / Treatment

-

Contacts and Locations

El Paso

William Beaumont Army Medical Center, El Paso, Texas, United States, 79934

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

William Beaumont Army Medical Center,

Eric P Ahnfeldt, DO, PRINCIPAL_INVESTIGATOR, Residency Program Director

Study Record Dates

2021-03