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

NCT01020058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2016-01-06

No results posted yet for this study

Summary

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.

Conditions

  • Hernia, Inguinal

Interventions

PROCEDURE

Mesh repair for primary inguinal hernia

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

Sponsors & Collaborators

  • Uppsala County Council, Sweden

    collaborator OTHER_GOV

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Staffan Wollert, MD, PhD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2012-03-31
Completion
2012-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020058 on ClinicalTrials.gov