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Hernia Prevention in Stomas

NCT00907842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-04-08

No results posted yet for this study

Summary

Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.

Conditions

  • Incisional Hernia
  • Parastomal Hernia

Interventions

DEVICE

Parietex Parastomal Mesh

mesh placed intraperitoneally around the stoma

Sponsors & Collaborators

  • Marc Schreinemacher

    lead OTHER

Principal Investigators

  • Nicole Bouvy, MD, PhD · Maastricht University Medical Centre

  • Marc Schreinemacher, MD · Maastricht University Medical Centre

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-02-28
Completion
2013-04-30

Countries

  • Netherlands

Study Locations

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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 NCT00907842 on ClinicalTrials.gov