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OpenTrials
Completed

NCT Number: NCT00788554

LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015CE, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • informed consent
  • age > 18 years
  • inguinal hernia(primary, recurrence or bilateral)
  • elective procedure

Exclusion criteria

  • Scrotal hernia
  • Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
  • Participation in other trial
  • Pregnancy
  • Communicative or cognitive restrictions

Treatment and study plan

Lichtenstein procedure

Procedure

open surgical procedure for inguinal hernia correction

TEP

Procedure

Total Exta Peritoneal procedure for inguinal hernia correction

Primary outcomes

  1. hospital stay

    Time frame: 7 days

  2. postoperative pain

    Time frame: 6 weeks

  3. return to work

    Time frame: 6 weeks

  4. quality of life

    Time frame: 5 years

Secondary outcomes

  1. operating time

    Time frame: 1 day

  2. operating costs

    Time frame: 1 week

  3. complication

    Time frame: 1 month

  4. mortality

    Time frame: 5 years

  5. total costs

    Time frame: 1 month

  6. recurrence

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.

Acronym: LEVEL

Important dates

Study start
2000
Primary completion
2004
Study completion
2011
First posted
Nov 11, 2008
Registry last updated
Aug 19, 2011

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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