NCT00254072

Brief Summary

Laparoscopic gastric bypass surgery is a common procedure being performed for the treatment of morbid obesity. The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy. Potential complications after gastric bypass include gastrointestinal bleeding and leaks. Gastrointestinal bleeding can occur at any staple line including the gastrojejunostomy. Potential methods for prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis or the use of a smaller stapler height. We hypothesize that the use of staplers with smaller staple height will significantly result in a lower rate of staple line bleeding and possible leaks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

2.2 years

First QC Date

October 31, 2005

Results QC Date

November 5, 2009

Last Update Submit

February 11, 2010

Conditions

Morbid Obesity

Keywords

Morbid ObesityLaparoscopic Gastric BypassStaple Line Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Postoperative Gastrointestinal Hemorrhage

    30 days

Study Arms (2)

Smaller Stapler

ACTIVE COMPARATOR

3.5 mm Circular Stapler

Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

Larger Stapler

ACTIVE COMPARATOR

4.8 mm Circular Stapler

Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

Interventions

3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric BypassPROCEDURE

The procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy.

Also known as: Covidien small 3.5 mm Circular Stapler, Covidien large 4.8 mm Circular Stapler
Larger StaplerSmaller Stapler

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 40-60 kg/m2
  • BMI of 35 kg/m2 with comorbidities

You may not qualify if:

  • large abdominal ventral hernia
  • large hiatal hernia,
  • history of liver cirrhosis
  • history of venous thrombosis or pulmonary embolism, coagulopathy or
  • Pregnant women
  • All physician, hospital, surgery, and laboratory costs will be billed to the subject or their insurance carriers as customary. The 3.5mm circular stapler is an FDA approved product and it will also be billed to the subject or insurer in the customary fashion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Tampa General Hospital- University of South Florida

Tampa, Florida, 33601, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

New York Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Ohio State University

Columbus, Ohio, 43210-1228, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9156, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

* Difficulty discerning GI bleeding attributed to the gastrojejunostomy vs gastric pouch staple-line * Technological differences between 3.5mm vs 4.8 mm stapler * Operative techniques varying between study sites * Study size may be underpowered

Results Point of Contact

Title
Ninh T. Nguyen, M.D.
Organization
UC Irvine Medical Center
ninhn@uci.edu
714-456-8580

Study Officials

  • Ninh T Nguyen, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 15, 2005

Study Start

January 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 18, 2010

Results First Posted

January 18, 2010

Record last verified: 2010-02

Locations

US(6)