Sleeve Gastrectomy Outcomes With Different Stapling Devices
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2018 |
| Start Date: | January 22, 2018 |
| End Date: | March 2021 |
| Contact: | Chelsey A McKinnon, MD |
| Email: | chelsey.a.mckinnon.mil@mail.mil |
| Phone: | 915 742 2282 |
Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices
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.
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.
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.
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.
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
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