Hernia Prevention in Stomas

April 5, 2013 updated by: Marc Schreinemacher

Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6200 AZ
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with a life expectancy of at least one year
  • Temporary stoma formation
  • Signed informed consent
  • Elective surgery
  • Clean-contaminated abdomen

Exclusion Criteria:

  • American Society of Anaesthesiologists (ASA) score IV or above
  • Incapacitated adult or no signed informed consent
  • Emergency procedure
  • Contaminated or infected abdomen
  • Residual intraperitoneal mesh
  • Already injured part of the abdominal wall where the stoma will be sited
  • Contraindication to laparoscopy
  • Longterm use of corticosteroids and other immunosuppressive agents
  • Current antibiotic therapy
  • One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mesh placement
Device: Parietex Parastomal Mesh
mesh placed intraperitoneally around the stoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
Time Frame: one year after placement
one year after placement
incisional herniation at the old stoma wound
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
Time Frame: two years after placement
two years after placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Schreinemacher

Investigators

  • Study Director: Nicole Bouvy, MD, PhD, Maastricht University Medical Centre
  • Principal Investigator: Marc Schreinemacher, MD, Maastricht University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 21, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC09-2-052
  • NL27625.068.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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