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Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

NCT ID: NCT01699971

Last Updated: 2012-10-04

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-03-31

Brief Summary

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The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lichtenstein

Hernia repair with lichtenstein propylene mesh

Group Type ACTIVE_COMPARATOR

Hernia repair

Intervention Type PROCEDURE

Hernia repair admodum Lichtenstein with polypropylene mesh

Hernia repair

Intervention Type PROCEDURE

Hernia repair with Ultra Pro Hernia System (UHS)

Hernia repair

Intervention Type PROCEDURE

Hernia repair with Prolene Hernia System(PHS)

Interventions

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Hernia repair

Hernia repair admodum Lichtenstein with polypropylene mesh

Intervention Type PROCEDURE

Hernia repair

Hernia repair with Ultra Pro Hernia System (UHS)

Intervention Type PROCEDURE

Hernia repair

Hernia repair with Prolene Hernia System(PHS)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-75 years
* unilateral primary hernia
* open surgery

Exclusion Criteria

* Recurrent Hernia
* Bilateral Hernia
* laparoscopic surgery
* Female
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anders Thorell

Assoc prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Thorell, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Ersta Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2006/672-31/4

Identifier Type: -

Identifier Source: org_study_id