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

Not Applicable

Completed

• Conditions: Unilateral Inguinal Hernia
• Interventions: Device: Rebound HRD Mesh

• Registration Number: NCT01622712
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Study Start: 2013-02-01
• Primary Completion: 2014-09-02
• Study Completion: 2014-09-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 235

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unilateral inguinal hernia	Rebound HRD Mesh	A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.

Primary Outcome Measures

Name	Time	Method
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.	12 months post-surgery	A CT scan is performed.

Secondary Outcome Measures

Name	Time	Method
Recurrence of hernia.	after 1 year
Pain assessment.	after 1 year
Wound morbidity.	after 4 weeks
Discomfort assessment.	after 1 year
Use of oral analgetics.	after 1 year

Trial Locations

Locations (2)

ASZ Aalst; 🇧🇪 Aalst, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium