MedTrace Logo

Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

NCT02121743 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-03-13

No results posted yet for this study

Summary

In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.

Conditions

  • Parastomal Hernia
  • Terminal Colostomy

Interventions

DEVICE

strattice

use of a strattice

PROCEDURE

No strattice

no use of a strattice

Sponsors & Collaborators

  • LifeCell

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • jean marc regimbeau, MD, PhD · CHU Amiens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-14
Primary Completion
2018-12-01
Completion
2023-12-01

Countries

  • France

Study Locations

More Related Trials

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 NCT02121743 on ClinicalTrials.gov