Elective Neurectomy During Inguinal Hernia Repair

This study has been completed.
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00492804
First received: June 26, 2007
Last updated: January 25, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Martin Turnheer, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00492804     History of Changes
Other Study ID Numbers: 05/015/2B
Study First Received: June 26, 2007
Last Updated: January 25, 2013
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Chronic Pain
Pathological Conditions, Anatomical
Hernia, Abdominal
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014