Elective Neurectomy During Inguinal Hernia Repair

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00492804
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 74
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Inguinal Hernia	Procedure: Lichtenstein hernia repair; Procedure: Neurectomy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• 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
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of postoperative pain [up to three years]

Secondary Outcome Measures

1. Incidence of hypesthesia or paraesthesia [one and three years]

2. Recurrence rate [one and three years]

3. Rate of intra- and postoperative complications [one and three years]

4. Quality of life [one and three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the Department of Surgery, Cantonal Hospital St. Gallen

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00492804
• Other Study ID Numbers: 05/015/2B
• First Posted: Jun 27, 2007
• Last Update Posted: Jan 28, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by , ,: inguinal hernia; chronic pain; neurectomy; hypesthesia
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Jan 28, 2013