RECRUITING

Sleeve Gastrectomy Outcomes With Different Stapling Devices

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices

Quick Facts

Study Start:2018-01-22
Study Completion:2021-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02731079

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Informed consent obtained and signed from each subject
  2. 2. Age ≥ 18 years
  3. 3. Requirement for agreement to avoid conception
  4. 4. BMI \>40
  5. 5. BMI \>35 with obesity-related co-morbidity
  6. 6. Pre-operative psychiatric evaluation
  7. 7. Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity
  8. 8. Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy
  1. 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. 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. 3. Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications
  4. 4. Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results
  5. 5. Active duty military- Not eligible for bariatric surgery

Contacts and Locations

Study Contact

Chelsey A McKinnon, MD
CONTACT
915 742 2282
chelsey.a.mckinnon.mil@mail.mil
Daniel J Roubik, MD
CONTACT
915-742-2282
daniel.j.roubik.mil@mail.mil

Principal Investigator

Eric P Ahnfeldt, DO
PRINCIPAL_INVESTIGATOR
Residency Program Director

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: William Beaumont Army Medical Center

  • Eric P Ahnfeldt, DO, PRINCIPAL_INVESTIGATOR, Residency Program Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-22
Study Completion Date2021-03

Study Record Updates

Study Start Date2018-01-22
Study Completion Date2021-03

Terms related to this study

Keywords Provided by Researchers

  • Sleeve gastrectomy stapler Covidien Ethicon bleeding leak

Additional Relevant MeSH Terms

  • Morbid Obesity