Sleeve Gastrectomy Outcomes With Different Stapling Devices
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|ClinicalTrials.gov Identifier: NCT02731079|
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Device: Covidien iDrive Device: Ethicon Echilon||Not Applicable|
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they will still receive surgery and perioperative treatment in line with institutional protocol, and they will be withdrawn and create a vacancy for a new subject.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices|
|Actual Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Active Comparator: Covidien
Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement.
Device: Covidien iDrive
Surgery performed with Covidien powered stapler
Active Comparator: Ethicon
Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement.
Device: Ethicon Echilon
Surgery performed with Ethicon powered stapler
- Time to create sleeve [ Time Frame: Time from first staple firing to last staple firing, for up to 5 hours ]
- Percent of staple firings with technical difficulties [ Time Frame: Time from first staple firing to last staple firing, for up to 5 hours ]
- Time to load staple cartridges [ Time Frame: Time from first staple firing to last staple firing, for up to 5 hours ]
- Intra-operative staple line bleeding [ Time Frame: Time from first staple firing to end of the case, for up to 5 hours ]Will note any incidental bleeding along staple line and how many maneuvers were needed to control it. Measured as: 1) None, 2) Single therapy, 3) Multiple therapy (Any combination of hemostatic modalities)
- Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year [ Time Frame: Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation ]
- Staple line leak rates [ Time Frame: Immediate post-operative period to conclusion of study, for up to 5 hours ]
- Hospital readmissions or emergency room visits [ Time Frame: Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation ]Will note reason for readmission
- Sleeve-related complications requiring surgery, recorded as yes or no [ Time Frame: Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation ]Will note intervention required and indication; reasons include, but are not limiting to, staple line leak, hematoma, abscess, prolonged tachycardia suspicious for intra-abdominal pathology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731079
|Contact: Chelsey A McKinnon, MD||915 742 firstname.lastname@example.org|
|Contact: Daniel J Roubik, MDemail@example.com|
|Principal Investigator:||Eric P Ahnfeldt, DO||Residency Program Director|