NCT01622712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2014

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

June 15, 2012

Last Update Submit

December 28, 2022

Conditions

Unilateral Inguinal Hernia

Keywords

inguinal hernia

Outcome Measures

Primary Outcomes (1)

  • Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.

    A CT scan is performed.

    12 months post-surgery

Secondary Outcomes (5)

  • Pain assessment.

    after 1 year

  • Discomfort assessment.

    after 1 year

  • Use of oral analgetics.

    after 1 year

  • Wound morbidity.

    after 4 weeks

  • Recurrence of hernia.

    after 1 year

Study Arms (1)

Unilateral inguinal hernia

EXPERIMENTAL

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

Device: Rebound HRD Mesh

Interventions

Rebound HRD MeshDEVICE

Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

Unilateral inguinal hernia

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ASZ Aalst

Aalst, 9300, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Berrevoet, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

February 1, 2013

Primary Completion

September 2, 2014

Study Completion

September 2, 2014

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

BE(2)