NCT02731079

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

March 30, 2016

Results QC Date

February 16, 2024

Last Update Submit

January 8, 2026

Conditions

Morbid Obesity

Keywords

Sleeve gastrectomy stapler Covidien Ethicon bleeding leak

Outcome Measures

Primary Outcomes (3)

  • Time

    Time to create sleeve.

    Time from first staple firing to last staple firing, for up to 5 hours

  • Staple Firings With Technical Difficulties

    Percent of staple firings with technical difficulties

    Time from first staple firing to last staple firing, for up to 5 hours

  • Load Time

    Time to load staple cartridges

    Time from first staple firing to last staple firing, for up to 5 hours

Secondary Outcomes (5)

  • Intra-operative Staple Line Bleeding

    Time from first staple firing to end of the case, for up to 5 hours

  • Weight Loss

    Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation

  • Leak Rates

    Immediate post-operative period to conclusion of study, for up to 5 hours

  • Readmissions

    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

    Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation

Study Arms (2)

Covidien

ACTIVE COMPARATOR

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

Device: Covidien iDrive

Ethicon

ACTIVE COMPARATOR

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

Device: Ethicon Echilon

Interventions

Covidien iDriveDEVICE

Surgery performed with Covidien powered stapler

Covidien
Ethicon EchilonDEVICE

Surgery performed with Ethicon powered stapler

Ethicon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained and signed from each subject
  • Age ≥ 18 years
  • Requirement for agreement to avoid conception
  • BMI \>40
  • BMI \>35 with obesity-related co-morbidity
  • Pre-operative psychiatric evaluation
  • Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity
  • Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy

You may not qualify if:

  • Pregnancy- Patients are not eligible for bariatric surgery, and if they become pregnant after surgery, they would present confounding variables and alter weight loss
  • 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
  • Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications
  • Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results
  • Active duty military- Not eligible for bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Army Medical Center

El Paso, Texas, 79934, United States

Location

Related Publications (12)

  • Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

    PMID: 24570244BACKGROUND

  • Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21.

    PMID: 23177371BACKGROUND

  • Marceau P, Hould FS, Simard S, Lebel S, Bourque RA, Potvin M, Biron S. Biliopancreatic diversion with duodenal switch. World J Surg. 1998 Sep;22(9):947-54. doi: 10.1007/s002689900498.

    PMID: 9717420BACKGROUND

  • Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000 Dec;10(6):514-23; discussion 524. doi: 10.1381/096089200321593715.

    PMID: 11175958BACKGROUND

  • Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003 Dec;13(6):861-4. doi: 10.1381/096089203322618669.

    PMID: 14738671BACKGROUND

  • ASMBS Clinical Issues Committee. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012 May-Jun;8(3):e21-6. doi: 10.1016/j.soard.2012.02.001. Epub 2012 Feb 10. No abstract available.

    PMID: 22417852BACKGROUND

  • D'Ugo S, Gentileschi P, Benavoli D, Cerci M, Gaspari A, Berta RD, Moretto C, Bellini R, Basso N, Casella G, Soricelli E, Cutolo P, Formisano G, Angrisani L, Anselmino M. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Dis. 2014 May-Jun;10(3):450-4. doi: 10.1016/j.soard.2013.10.018. Epub 2013 Nov 12.

    PMID: 24448100BACKGROUND

  • Gentileschi P, Camperchioli I, D'Ugo S, Benavoli D, Gaspari AL. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc. 2012 Sep;26(9):2623-9. doi: 10.1007/s00464-012-2243-2. Epub 2012 Mar 23.

    PMID: 22441975BACKGROUND

  • Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg. 2013;11(4):286-9. doi: 10.1016/j.ijsu.2013.02.015. Epub 2013 Feb 28.

    PMID: 23459188BACKGROUND

  • Sroka G, Milevski D, Shteinberg D, Mady H, Matter I. Minimizing Hemorrhagic Complications in Laparoscopic Sleeve Gastrectomy--a Randomized Controlled Trial. Obes Surg. 2015 Sep;25(9):1577-83. doi: 10.1007/s11695-015-1580-3.

    PMID: 25596939BACKGROUND

  • Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):713-23. doi: 10.1016/j.soard.2014.01.016. Epub 2014 Jan 28.

    PMID: 24745978BACKGROUND

  • Huang R, Gagner M. A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2360-7. doi: 10.1007/s11695-015-1705-8.

    PMID: 26024735BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Eric Ahnfeldt
Organization
William Beaumont Army Medical Center
eric.p.ahnfeldt.mil@health.mil
915-742-4442

Study Officials

  • Eric P Ahnfeldt, DO

    Residency Program Director

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Human Protection Director

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 7, 2016

Study Start

January 22, 2018

Primary Completion

December 22, 2020

Study Completion

December 22, 2020

Last Updated

January 12, 2026

Results First Posted

January 12, 2026

Record last verified: 2026-01

Locations

US(1)