Sleeve Gastrectomy Outcomes With Different Stapling Devices

NCT ID: NCT02731079

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2020-12-22

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Covidien

Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement.

Group Type: ACTIVE_COMPARATOR

Covidien iDrive

Intervention Type: DEVICE

Surgery performed with Covidien powered stapler

Ethicon

Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement.

Group Type: ACTIVE_COMPARATOR

Ethicon Echilon

Intervention Type: DEVICE

Surgery performed with Ethicon powered stapler

Interventions

Covidien iDrive

Surgery performed with Covidien powered stapler

Intervention Type: DEVICE

Ethicon Echilon

Surgery performed with Ethicon powered stapler

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edna Rath

FED

Sponsor Role: lead

Responsible Party

Edna Rath

Human Protection Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eric P Ahnfeldt, DO

Role: PRINCIPAL_INVESTIGATOR

Residency Program Director

Locations

William Beaumont Army Medical Center

El Paso, Texas, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

WB16-08

Identifier Type: -

Identifier Source: org_study_id