Elective Neurectomy During Inguinal Hernia Repair - Full Text View

Sponsored by:	Cantonal Hospital of St. Gallen
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00492804

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 II

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-Blind, Randomized, Controlled Clinical Trial

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

Primary Outcome Measures:

Incidence of postoperative pain [ Time Frame: one and 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 ]

Estimated Enrollment:	200
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2009

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492804

Contacts

Contact: Martin Thurnheer, MD

041 71 494 13 38

martin.thurnheer@kssg.ch

Locations

Switzerland, SG
Department of Surgery, Cantonal Hospital of St. Gallen	Recruiting
St. Gallen, SG, Switzerland, 9007
Contact: Martin Thurnheer, MD +41 71 494 1338 martin.thurnheer@kssg.ch
Contact: Christoph Zeisel, MD +41 71 494 1111 christoph.zeisel@kssg.ch
Principal Investigator: Martin Thurnheer, MD

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Investigators

Principal Investigator:

Martin Thurnheer, MD

Department of Surgery, Cantonal Hospital St. Gallen

More Information

Website of the Department of Surgery, Cantonal Hospital St. Gallen This link exits the ClinicalTrials.gov site

Study ID Numbers:	05/015/2B
Study First Received:	June 26, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00492804
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:

inguinal hernia
chronic pain
neurectomy
hypesthesia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hypesthesia

Hernia, Abdominal
Pain
Hernia, Inguinal

ClinicalTrials.gov processed this record on February 06, 2009