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Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

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ClinicalTrials.gov Identifier: NCT00568269
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : December 6, 2007
Sponsor:
Collaborators:
Stig and Ragna Gorthon Foundation
Tyco Healthcare Group
Information provided by:
Uppsala University Hospital

Brief Summary:
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Open repair Procedure: Laparoscopic repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1513 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
Study Start Date : November 1996
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lichtenstein Procedure: Open repair
Open repair is according to the Lichtenstein technique
Experimental: TEP Procedure: Laparoscopic repair
The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair



Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Operative complications, postoperative recovery and chronic pain at 5 years. [ Time Frame: 5 years ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion Criteria:

  • Recurrent hernia
  • Scrotal or bilateral hernia
  • Previous lower abdominal surgery
  • Unable to participate in follow up
  • ASA more than 3
  • Bleeding diathesis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568269


Locations
Sweden
Centre for Clinical Research, Central hospital, entrance 29
Västerås, Sweden, 721 89
Sponsors and Collaborators
Uppsala University Hospital
Stig and Ragna Gorthon Foundation
Tyco Healthcare Group
Investigators
Principal Investigator: Arne S Eklund, MD Centre for Clinical Research

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arne Eklund, MD, Centre for Clinical Research
ClinicalTrials.gov Identifier: NCT00568269     History of Changes
Other Study ID Numbers: SMIL II
Ups 144-96
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

Keywords provided by Uppsala University Hospital:
Recurrence rate after inguinal hernia repair on primary inguinal herina.

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal