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Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

NCT00663819 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2018-04-17

Study results available
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Summary

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

Conditions

Interventions

DEVICE

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

PROCEDURE

Staple line without reinforcement

colorectal and coloanal anastomotic staple line without reinforcement

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Anthony J Senagore, MD, MBA, MS · University of Southern California, Keck School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663819 on ClinicalTrials.gov