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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
Sponsor:
Information provided by (Responsible Party):
Eric P Ahnfeldt, William Beaumont Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Covidien iDrive Device: Ethicon Echilon Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time to create sleeve [ Time Frame: Time from first staple firing to last staple firing, for up to 5 hours ]
  2. Percent of staple firings with technical difficulties [ Time Frame: Time from first staple firing to last staple firing, for up to 5 hours ]
  3. Time to load staple cartridges [ Time Frame: Time from first staple firing to last staple firing, for up to 5 hours ]

Secondary Outcome Measures :
  1. 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)

  2. 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 ]
  3. Staple line leak rates [ Time Frame: Immediate post-operative period to conclusion of study, for up to 5 hours ]
  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


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

Locations
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United States, Texas
William Beaumont Army Medical Center Recruiting
El Paso, Texas, United States, 79934
Contact: Eric P Ahnfeldt, DO    915-742-4442    eric.p.ahnfeldt.mil@mail.mil   
Contact: Cara L Reitz, MD    5617045490    cara.l.reitz.mil@mail.mil   
Sponsors and Collaborators
William Beaumont Army Medical Center
Investigators
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Principal Investigator: Eric P Ahnfeldt, DO Residency Program Director
Publications:

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Responsible Party: Eric P Ahnfeldt, Principal Investigator, William Beaumont Army Medical Center
ClinicalTrials.gov Identifier: NCT02731079    
Other Study ID Numbers: WB16-08
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eric P Ahnfeldt, William Beaumont Army Medical Center:
Sleeve gastrectomy stapler Covidien Ethicon bleeding leak
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight