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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01622712

Acronym

REBOUND

Enrollment

235

Registered

2012-06-19

Start date

2013-02-01

Completion date

2014-09-02

Last updated

2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Inguinal Hernia

Keywords

inguinal hernia

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.

Interventions

DEVICERebound HRD Mesh

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026