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

Primary Purpose

Unilateral Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rebound HRD Mesh
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Inguinal Hernia focused on measuring inguinal hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

Sites / Locations

  • ASZ Aalst
  • Ghent University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unilateral inguinal hernia

Arm Description

A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.

Outcomes

Primary Outcome Measures

Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
A CT scan is performed.

Secondary Outcome Measures

Pain assessment.
Discomfort assessment.
Use of oral analgetics.
Wound morbidity.
Recurrence of hernia.

Full Information

First Posted
June 15, 2012
Last Updated
December 28, 2022
Sponsor
University Hospital, Ghent
Collaborators
Medri
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1. Study Identification

Unique Protocol Identification Number
NCT01622712
Brief Title
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device
Acronym
REBOUND
Official Title
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
September 2, 2014 (Actual)
Study Completion Date
September 2, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Medri

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Inguinal Hernia
Keywords
inguinal hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral inguinal hernia
Arm Type
Experimental
Arm Description
A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.
Intervention Type
Device
Intervention Name(s)
Rebound HRD Mesh
Intervention Description
Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.
Primary Outcome Measure Information:
Title
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
Description
A CT scan is performed.
Time Frame
12 months post-surgery
Secondary Outcome Measure Information:
Title
Pain assessment.
Time Frame
after 1 year
Title
Discomfort assessment.
Time Frame
after 1 year
Title
Use of oral analgetics.
Time Frame
after 1 year
Title
Wound morbidity.
Time Frame
after 4 weeks
Title
Recurrence of hernia.
Time Frame
after 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASZ Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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

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