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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Unilateral Inguinal Hernia

Treatments: Device: Rebound HRD Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT01622712

2011/823

Details and patient eligibility

About

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.

Enrollment: 235 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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235 participants in 1 patient group

Unilateral inguinal hernia

Experimental group

Description:

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

Treatment:

Device: Rebound HRD Mesh