Elective Neurectomy During Inguinal Hernia Repair

January 25, 2013 updated by: Cantonal Hospital of St. Gallen

Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial

Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.

It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.

This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • SG
      • St. Gallen, SG, Switzerland, 9007
        • Department of surgery, Cantonal hospital of St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Uni- or bilateral inguinal hernia
  • Karnofsky-index ≥70
  • Informed consent

Exclusion Criteria:

  • Recurrent inguinal hernia
  • Previous inguinal operation
  • Emergent operation
  • Severe comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Neurectomy
Procedure: Lichtenstein hernia repair
Lichtenstein hernia repair with tension free mesh
Procedure: Neurectomy
Neurectomy
Other: Nerve preservation
Procedure: Lichtenstein hernia repair
Lichtenstein hernia repair with tension free mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative pain
Time Frame: up to three years
up to three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of hypesthesia or paraesthesia
Time Frame: one and three years
one and three years
Recurrence rate
Time Frame: one and three years
one and three years
Rate of intra- and postoperative complications
Time Frame: one and three years
one and three years
Quality of life
Time Frame: one and three years
one and three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Martin Thurnheer, MD, Department of Surgery, Cantonal Hospital St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/015/2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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