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

This study has been completed.
Sponsor:
Collaborators:
Stig and Ragna Gorthon Foundation
Tyco Healthcare Group
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT00568269
First received: December 5, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 ] [ Designated as safety issue: Yes ]

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

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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Additional 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
Study First Received: December 5, 2007
Last Updated: December 5, 2007
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on July 26, 2014