Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00323674

Enrollment

278

Registered

2006-05-09

Start date

2006-03-31

Completion date

2015-08-31

Last updated

2023-09-05

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

Conditions

Hernia, Inguinal

Keywords

Hernia Inguinalis

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.

Interventions

DEVICEPolysoft Mesh

Polysoft Mesh is used.

DEVICELight Weight Mesh

Light Weight Mesh is used.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Symptomatic hernia inguinalis * \> 18 years

Design outcomes

Primary

Measure	Time frame
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.

Countries

Belgium

Outcome results

None listed

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