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Elective Neurectomy During Inguinal Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492804
First Posted: June 27, 2007
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cantonal Hospital of St. Gallen
  Purpose

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.


Condition Intervention Phase
Inguinal Hernia Procedure: Lichtenstein hernia repair Procedure: Neurectomy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Incidence of postoperative pain [ Time Frame: up to three years ]

Secondary Outcome Measures:
  • Incidence of hypesthesia or paraesthesia [ Time Frame: one and three years ]
  • Recurrence rate [ Time Frame: one and three years ]
  • Rate of intra- and postoperative complications [ Time Frame: one and three years ]
  • Quality of life [ Time Frame: one and three years ]

Enrollment: 200
Study Start Date: July 2005
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Neurectomy Procedure: Lichtenstein hernia repair
Lichtenstein hernia repair with tension free mesh
Procedure: Neurectomy
Neurectomy
Nerve preservation Procedure: Lichtenstein hernia repair
Lichtenstein hernia repair with tension free mesh

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent inguinal hernia
  • Previous inguinal operation
  • Emergent operation
  • Severe comorbidities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492804


Locations
Switzerland
Department of Surgery, Cantonal Hospital of St. Gallen
St. Gallen, SG, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Martin Thurnheer, MD Department of Surgery, Cantonal Hospital St. Gallen
  More Information

Additional Information:
Responsible Party: Martin Turnheer, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00492804     History of Changes
Other Study ID Numbers: 05/015/2B
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Cantonal Hospital of St. Gallen:
inguinal hernia
chronic pain
neurectomy
hypesthesia

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal