- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00492804
Elective Neurectomy During Inguinal Hernia Repair
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
SG
-
St. Gallen, SG, Switzerland, 9007
- Department of surgery, Cantonal hospital of St. Gallen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Lichtenstein hernia repair with tension free mesh
Neurectomy
|
Other: Nerve preservation
|
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
Sponsor
Investigators
- Principal Investigator: Martin Thurnheer, MD, Department of Surgery, Cantonal Hospital St. Gallen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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