Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

August 31, 2023 updated by: University Hospital, Ghent

Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

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

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

Description

Inclusion Criteria:

  • Symptomatic hernia inguinalis
  • > 18 years

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Light Weight Mesh
Device: Light Weight Mesh
Light Weight Mesh is used.
Active Comparator: Polysoft Mesh
Device: Polysoft Mesh
Polysoft Mesh is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of relapse
Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Postoperative pain assessment
Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Duration to full recovery (able to do all activities)
Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Frederik Berrevoet, MD, University Hospital, Ghent

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.

Helpful Links

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 (Actual)

March 1, 2006

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

May 7, 2006

First Submitted That Met QC Criteria

May 7, 2006

First Posted (Estimated)

May 9, 2006

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/080

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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