Sleeve Gastrectomy Outcomes With Different Stapling Devices

January 8, 2026 updated by: Edna Rath

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79934
        • William Beaumont Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time
Time Frame: Time from first staple firing to last staple firing, for up to 5 hours
Time to create sleeve.
Time from first staple firing to last staple firing, for up to 5 hours
Staple Firings With Technical Difficulties
Time Frame: Time from first staple firing to last staple firing, for up to 5 hours
Percent of staple firings with technical difficulties
Time from first staple firing to last staple firing, for up to 5 hours
Load Time
Time Frame: Time from first staple firing to last staple firing, for up to 5 hours
Time to load staple cartridges
Time from first staple firing to last staple firing, for up to 5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time from first staple firing to end of the case, for up to 5 hours
Weight Loss
Time Frame: Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation
Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year
Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation
Leak Rates
Time Frame: Immediate post-operative period to conclusion of study, for up to 5 hours
Staple line leak rates
Immediate post-operative period to conclusion of study, for up to 5 hours
Readmissions
Time Frame: Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
Hospital readmissions or emergency room visits; Will note reason for readmission
Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation
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
Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edna Rath

Investigators

  • Principal Investigator: Eric P Ahnfeldt, DO, Residency Program Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

December 22, 2020

Study Completion (Actual)

December 22, 2020

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimated)

April 7, 2016

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WB16-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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