A Multi-Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Norwegian University of Science and Technology Sørlandet Sykehus, Arendal Voss Sykehus Haraldsplass Sykehus Østfold Sentralsykehus
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00184483

Purpose

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clincal examinations. End point is postoperativ pain and recurrences.

Condition	Intervention
Inguinal Hernia	Procedure: Surgery

MedlinePlus related topics: Hernia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Pain after surgery for groin hernia

Secondary Outcome Measures:

Recurrences after groin hernia repair

Estimated Enrollment:	500
Study Start Date:	October 2001
Estimated Study Completion Date:	January 2009

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary unilateral groin hernia in adult

Exclusion Criteria:

recurrence warfarin treatment bilateral groin hernia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184483

Locations

Norway
St Olavs Hospital
Trondheim, Norway, 7006

Sponsors and Collaborators

Norwegian University of Science and Technology

Sørlandet Sykehus, Arendal

Voss Sykehus

Haraldsplass Sykehus

Østfold Sentralsykehus

Investigators

Study Director:

Helge E Myrvold, MD PhD

NTNU

More Information

Responsible Party:	Norwegian University of Science and Technology ( Professor MD Helge E Myrvold )
Study ID Numbers:	Norwegian Hernia Study
Study First Received:	September 15, 2005
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00184483
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

Surgery
Lichtenstein
Prolene Hernia System
Postoperative pain
Recurrence

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Pain

Hernia, Inguinal
Recurrence
Pain, Postoperative

ClinicalTrials.gov processed this record on January 14, 2009