Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device (REBOUND)

December 28, 2022 updated by: University Hospital, Ghent

Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.

The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.

Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

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
      • Aalst, Belgium, 9300
        • ASZ Aalst
      • Ghent, Belgium, 9000
        • Ghent University Hospital

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

Male

Description

Inclusion Criteria:

  • elective repair for a primary unilateral inguinal hernia OR
  • elective repair for a recurrent unilateral inguinal hernia after non-mesh repair

Exclusion Criteria:

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral inguinal hernia
A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.
Device: Rebound HRD Mesh
Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
Time Frame: 12 months post-surgery
A CT scan is performed.
12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain assessment.
Time Frame: after 1 year
after 1 year
Discomfort assessment.
Time Frame: after 1 year
after 1 year
Use of oral analgetics.
Time Frame: after 1 year
after 1 year
Wound morbidity.
Time Frame: after 4 weeks
after 4 weeks
Recurrence of hernia.
Time Frame: after 1 year
after 1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

Medri

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)

February 1, 2013

Primary Completion (Actual)

September 2, 2014

Study Completion (Actual)

September 2, 2014

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/823

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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