Clinical trial NCT02731079: Sleeve Gastrectomy Outcomes With Different Stapling Devices
Official title: Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbid Obesity
Keywords: Sleeve gastrectomy stapler Covidien Ethicon bleeding leak
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2016-04-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: New bariatric patients who have elected for a sleeve gastrectomy as part of standard of care will be invited to participate in the study during the bariatric clinic at William Beaumont Army Medical Center. Patients who meet the inclusion criteria will be invited to participate in the study. These patients will be consented in the bariatric clinic by a research coordinator (Doreen Bandari-Spaulding) or physician listed on the study if the coordinator is unavailable.

Three folders will be made, one for each bariatric surgeon, and 25 Covidien cards and 25 Ethicon cards will be placed into each for a total of 150 patients. All bariatric surgeons are trained and familiar with both devices. Once consented, a card will be removed at random to determine which stapler will be used. Bioabsorbable staple line reinforcement will be utilized with both staplers. Once in the operating room, the case start time, time from first staple firing to completion of sleeve, total stapler loads required, number of staple misfires, character of any staple line bleeding, and time for tech to load each cartridge will be recorded on a data collection sheet by a research resident, listed as an associative investigator on this protocol. The subject's post-operative course will follow the bariatric protocol. During follow-up, they will be monitored for weight loss, post-operative complications, and any other required interventions. This information will be obtained by reviewing the subject's medical record after follow-up appointments. Per the institutional bariatric protocol, subjects will follow-up at 3 weeks, 6 weeks, 3 months, 6 months, and annually. If a subject withdraws consent for the study prior to surgery, they will still receive surgery and perioperative treatment in line with institutional protocol, and they will be withdrawn and create a vacancy for a new subject. If a subject withdraws consent after surgery, data collection will cease for that subject. The investigators will clarify whether they want all data to be removed from the study or if they simply want no more data to be entered into the study and abide by their wishes, and they will remain in the original randomized group in accordance with intention-to-treat principles.

Eligibility 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

Primary outcomes:
measure: Time to create sleeve
timeFrame: Time from first staple firing to last staple firing, for up to 5 hours
measure: Percent of staple firings with technical difficulties
timeFrame: Time from first staple firing to last staple firing, for up to 5 hours
measure: Time to load staple cartridges
timeFrame: Time from first staple firing to last staple firing, for up to 5 hours
Secondary outcomes:
measure: Intra-operative staple line bleeding
timeFrame: Time from first staple firing to end of the case, for up to 5 hours
measure: Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year
timeFrame: Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation
measure: Staple line leak rates
timeFrame: Immediate post-operative period to conclusion of study, for up to 5 hours
measure: Hospital readmissions or emergency room visits
timeFrame: Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
measure: Sleeve-related complications requiring surgery, recorded as yes or no
timeFrame: Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
Study officials:
affiliation: Residency Program Director
name: Eric P Ahnfeldt, DO
role: PRINCIPAL_INVESTIGATOR
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