Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

NCT ID: NCT00642200

Last Updated: 2008-05-22

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2007-04-30

Brief Summary

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The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Detailed Description

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Conditions

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Recurrent Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.

Group Type ACTIVE_COMPARATOR

Lichtenstein hernioplasty

Intervention Type PROCEDURE

2

Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.

Group Type ACTIVE_COMPARATOR

Laparoscopic TEP

Intervention Type PROCEDURE

Interventions

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Lichtenstein hernioplasty

Intervention Type PROCEDURE

Laparoscopic TEP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* recurrent inguinal hernia
* willing to participate

Exclusion Criteria

* unwilling to participate
* bilateral hernia
* preference towards either treatment arm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kuopio Computing Center

UNKNOWN

Sponsor Role collaborator

North Karelia Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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North Karelia Central Hospital, Clinic of Surgery

Locations

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North Karelia Central Hospital - Clinic of Surgery

Joensuu, Pohjois-Karjala, Finland

Site Status

Countries

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Finland

References

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Kouhia ST, Huttunen R, Silvasti SO, Heiskanen JT, Ahtola H, Uotila-Nieminen M, Kiviniemi VV, Hakala T. Lichtenstein hernioplasty versus totally extraperitoneal laparoscopic hernioplasty in treatment of recurrent inguinal hernia--a prospective randomized trial. Ann Surg. 2009 Mar;249(3):384-7. doi: 10.1097/SLA.0b013e318196d0b0.

Reference Type DERIVED
PMID: 19247022 (View on PubMed)

Other Identifiers

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NKCH-surg-001

Identifier Type: -

Identifier Source: org_study_id