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NCT00492804 Clinical Trial

Elective Neurectomy During Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:
Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00492804
Other study ID # 05/015/2B
Secondary ID
Status Completed
Phase Phase 2
First received June 26, 2007
Last updated January 25, 2013
Start date July 2005
Est. completion date September 2011

Study information
Verified date January 2013
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Lichtenstein hernia repair
Lichtenstein hernia repair with tension free mesh
• Neurectomy
Neurectomy

Locations
Country Name City State
Switzerland Department of Surgery, Cantonal Hospital of St. Gallen St. Gallen SG

Sponsors (1)
Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative pain up to three years
Secondary Incidence of hypesthesia or paraesthesia one and three years
Secondary Recurrence rate one and three years
Secondary Rate of intra- and postoperative complications one and three years
Secondary Quality of life one and three years
See also
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Recruiting NCT03904888 - Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair N/A
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Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
Completed NCT01679353 - Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair N/A
Completed NCT01943760 - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty Phase 4
Recruiting NCT01450345 - Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain Phase 3
Active, not recruiting NCT00968773 - Rebound Hernia Repair Device Mesh Trial Phase 4
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Completed NCT01117337 - Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair Phase 4
Terminated NCT00226161 - Chronic Pain After Inguinal Herniorrhaphy N/A
Completed NCT05837013 - Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia N/A
Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
Completed NCT01637818 - Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair N/A
Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A

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