Use of a Mesh to Prevent Parastomal Hernia

September 14, 2015 updated by: Corporacion Parc Tauli

Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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:

  • patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
  • Aged over 18,
  • Charlson comorbidity index below 7
  • Elective surgery
  • Radical surgery

Exclusion Criteria:

  • Loop colostomies,
  • Emergency surgery,
  • Body mass index above 35 kg/sq.m.,
  • Palliative surgery,
  • Hepatic cirrhosis,
  • Severe COPD (requiring home oxygen treatment),
  • Corticoid treatment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®
Device: Mesh (Ultrapro ®)
In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy
Other Names:
  • Ultrapro ®
Procedure: Conventional sigmoid end colostomy
Patients receiving conventional sigmoid end colostomy, without mesh
Other: 2
Patients receiving conventional sigmoid end colostomy, without mesh
Procedure: Conventional sigmoid end colostomy
Patients receiving conventional sigmoid end colostomy, without mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the reduction in the incidence of Parastomal Hernia after the mesh placement
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Corporacion Parc Tauli

Investigators

  • Study Chair: Salvador Navarro-Soto, MD, Corporacio Sanitaria Parc Tauli

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, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPT-SerraA-01

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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