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

This study has been completed.
Stig and Ragna Gorthon Foundation
Tyco Healthcare Group
Information provided by:
Uppsala University Hospital Identifier:
First received: December 5, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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 Intervention
Inguinal Hernia
Procedure: Open repair
Procedure: Laparoscopic repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Resource links provided by NLM:

Further study details as provided by Uppsala University Hospital:

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

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

Enrollment: 1513
Study Start Date: November 1996
Study Completion Date: December 2007
Arms Assigned Interventions
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


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

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.
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Please refer to this study by its identifier: NCT00568269

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
Principal Investigator: Arne S Eklund, MD Centre for Clinical Research
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arne Eklund, MD, Centre for Clinical Research Identifier: NCT00568269     History of Changes
Other Study ID Numbers: SMIL II
Ups 144-96
Study First Received: December 5, 2007
Last Updated: December 5, 2007

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

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal processed this record on May 23, 2017