Comparison of Three Meshes in Lichtenstein Hernia Repair

NCT ID: NCT01295437

Last Updated: 2011-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2011-01-31

Brief Summary

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Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).

Detailed Description

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Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.

Conditions

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Chronic Pain Recurrences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vypro II mesh

A partly absorbable polypropylene-polyglactin mesh (50g/m2).

Group Type ACTIVE_COMPARATOR

Vypro II mesh

Intervention Type DEVICE

partly absorbable mesh

Premilene LP

A lightweight polypropylene mesh (55 g/m2)

Group Type ACTIVE_COMPARATOR

Premilene LP

Intervention Type DEVICE

lightweight mesh

Premilene mesh

A conventional polypropylene mesh (82 g/m2)

Group Type PLACEBO_COMPARATOR

Premilene mesh

Intervention Type DEVICE

A conventional polypropylene mesh (82 g/m2)

Interventions

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Vypro II mesh

partly absorbable mesh

Intervention Type DEVICE

Premilene LP

lightweight mesh

Intervention Type DEVICE

Premilene mesh

A conventional polypropylene mesh (82 g/m2)

Intervention Type DEVICE

Other Intervention Names

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polypropylene-polyglactin mesh lightweight polypropylene polypropylene mesh

Eligibility Criteria

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Inclusion Criteria

* uni-or bilateral primary or recurrent inguinal hernia
* patients age \>18yrs

Exclusion Criteria

* previous mesh hernioplasty
* femoral hernia
* emergency operation
* allergy to polypropylene
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mikkeli Central Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Surgery, Kuopio University Hospital, Kuopio, Finland

Principal Investigators

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Hannu EK Paajanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Kuopio, Finland

Locations

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Hannu Paajanen

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia. 2007 Aug;11(4):335-9. doi: 10.1007/s10029-007-0236-1. Epub 2007 May 10.

Reference Type BACKGROUND
PMID: 17492341 (View on PubMed)

Paajanen H, Ronka K, Laurema A. A single-surgeon randomized trial comparing three meshes in lichtenstein hernia repair: 2- and 5-year outcome of recurrences and chronic pain. Int J Surg. 2013;11(1):81-4. doi: 10.1016/j.ijsu.2012.11.020. Epub 2012 Dec 13.

Reference Type DERIVED
PMID: 23246868 (View on PubMed)

Other Identifiers

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Lichtenstein

Identifier Type: OTHER

Identifier Source: secondary_id

Lichtenstein hernia repair

Identifier Type: -

Identifier Source: org_study_id

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