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Completed

NCT Number: NCT01020058

Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Enköping Hospital, Enköping, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Unilateral inguinal hernia
  • suitable for open mesh repair in local anesthesia as well as laparoscopic repair
  • ASA score I-III
  • informed consent

Exclusion criteria

  • ASA score IV (not suitable for TEP)
  • bilateral hernias (laparoscopic repair preferable)
  • recurrent hernia (primary repair affects preferable treatment)
  • large scrotal hernias (not suitable for local anesthesia)
  • earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)

Treatment and study plan

Mesh repair for primary inguinal hernia

Procedure

Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh

Other names: Lichtenstein (LLA), TEP

Primary outcomes

  1. long-term post operative pain

    Time frame: 6 wks, 1 year

Secondary outcomes

  1. cost-effectiveness of the separate procedures

    Time frame: 6wks, 1year

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Uppsala County Council, Sweden

Registry information

Official study title

Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2009
Registry last updated
Jan 6, 2016

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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