Evaluation of Mesh Integration and Mesh Contraction After... | NCT01622712

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

NCT01622712

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 29, 2022Actual

Enrollment

235Actual

Phase

Not Applicable

Conditions

Unilateral Inguinal Hernia

Interventions

Rebound HRD Mesh

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2013Actual

Primary Completion Date

Sep 2, 2014Actual

Completion Date

Sep 2, 2014Actual

First Submitted Date

Jun 15, 2012

First Submission Date that Met QC Criteria

Jun 18, 2012

First Posted Date

Jun 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2022

Last Update Posted Date

Dec 29, 2022Actual

Name	Class
Medri	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

235Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rebound HRD Mesh	Device	Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.	Unilateral inguinal hernia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pain assessment.		after 1 year
Discomfort assessment.		after 1 year
Use of oral analgetics.

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Berrevoet, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASZ Aalst		Aalst		9300	Belgium
Ghent University Hospital

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided