NCT00323674

Brief Summary

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

9.4 years

First QC Date

May 7, 2006

Last Update Submit

August 31, 2023

Conditions

Hernia, Inguinal

Keywords

Hernia Inguinalis

Outcome Measures

Primary Outcomes (3)

  • Percentage of relapse

    Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

  • Postoperative pain assessment

    Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

  • Duration to full recovery (able to do all activities)

    Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

Study Arms (2)

Light Weight Mesh

ACTIVE COMPARATOR
Device: Light Weight Mesh

Polysoft Mesh

ACTIVE COMPARATOR
Device: Polysoft Mesh

Interventions

Polysoft MeshDEVICE

Polysoft Mesh is used.

Polysoft Mesh
Light Weight MeshDEVICE

Light Weight Mesh is used.

Light Weight Mesh

Eligibility Criteria

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

You may qualify if:

  • Symptomatic hernia inguinalis
  • \> 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

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

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 7, 2006

First Posted

May 9, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2015

Study Completion

August 31, 2015

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

BE(1)