Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia

March 23, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach

The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.

Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.

Study Type

Interventional

Enrollment (Actual)

36

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

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Valldhebron Research Institute

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 with permanent ostomy and 1 years of life expectancy
  • Signed informed consent

Exclusion Criteria:

  • Allergy to the compounds of the mesh
  • Rejection of the patient
  • Rejection of the surgeon
  • Field of emergency
  • Life expectancy < 1 year
  • Prior meshes in the surgical site

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic mesh
All patients will have a permanent ostomy and a randomisation with prophylactic mesh
Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Other Names:
  • PROCEED mesh
No Intervention: without prophylactic mesh
All patients will have a permanent ostomy and a randomisation without prophylactic mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done
Time Frame: 24 to 36 months after surgery
24 to 36 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Measuring the quality of life using the SF-36
Time Frame: Preoperative and at the end of the study
Preoperative and at the end of the study

Collaborators and Investigators

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

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

November 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 25, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)116/2006

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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