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Elective Neurectomy During Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Lichtenstein hernia repair
Neurectomy
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring inguinal hernia, chronic pain, neurectomy, hypesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Uni- or bilateral inguinal hernia
  • Karnofsky-index ≥70
  • Informed consent

Exclusion Criteria:

  • Recurrent inguinal hernia
  • Previous inguinal operation
  • Emergent operation
  • Severe comorbidities

Sites / Locations

  • Department of Surgery, Cantonal Hospital of St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Neurectomy

Nerve preservation

Arm Description

Outcomes

Primary Outcome Measures

Incidence of postoperative pain

Secondary Outcome Measures

Incidence of hypesthesia or paraesthesia
Recurrence rate
Rate of intra- and postoperative complications
Quality of life

Full Information

First Posted
June 26, 2007
Last Updated
January 25, 2013
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT00492804
Brief Title
Elective Neurectomy During Inguinal Hernia Repair
Official Title
Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, chronic pain, neurectomy, hypesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurectomy
Arm Type
Other
Arm Title
Nerve preservation
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein hernia repair
Intervention Description
Lichtenstein hernia repair with tension free mesh
Intervention Type
Procedure
Intervention Name(s)
Neurectomy
Intervention Description
Neurectomy
Primary Outcome Measure Information:
Title
Incidence of postoperative pain
Time Frame
up to three years
Secondary Outcome Measure Information:
Title
Incidence of hypesthesia or paraesthesia
Time Frame
one and three years
Title
Recurrence rate
Time Frame
one and three years
Title
Rate of intra- and postoperative complications
Time Frame
one and three years
Title
Quality of life
Time Frame
one and three years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Thurnheer, MD
Organizational Affiliation
Department of Surgery, Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Cantonal Hospital of St. Gallen
City
St. Gallen
State/Province
SG
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.surgery.ch
Description
Website of the Department of Surgery, Cantonal Hospital St. Gallen

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Elective Neurectomy During Inguinal Hernia Repair

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