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Completed

NCT Number: NCT00568269

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

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

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Key information

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Clinical Research, Central hospital, entrance 29

Västerås, 721 89, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Repair

Procedure

Open repair is according to the Lichtenstein technique

Laparoscopic repair

Procedure

The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair

Primary outcomes

  1. Recurrence rate

    Time frame: 5 years

Secondary outcomes

  1. Operative complications, postoperative recovery and chronic pain at 5 years.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Stig and Ragna Gorthon Foundation
  • Tyco Healthcare Group

Registry information

Important dates

Study start
1996
Study completion
2007
First posted
Dec 6, 2007
Registry last updated
Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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