NCT00492804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

5.7 years

First QC Date

June 26, 2007

Last Update Submit

January 25, 2013

Conditions

Inguinal Hernia

Keywords

inguinal herniachronic painneurectomyhypesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative pain

    up to three years

Secondary Outcomes (4)

  • Incidence of hypesthesia or paraesthesia

    one and three years

  • Recurrence rate

    one and three years

  • Rate of intra- and postoperative complications

    one and three years

  • Quality of life

    one and three years

Study Arms (2)

Neurectomy

OTHER
Procedure: Lichtenstein hernia repairProcedure: Neurectomy

Nerve preservation

OTHER
Procedure: Lichtenstein hernia repair

Interventions

Lichtenstein hernia repairPROCEDURE

Lichtenstein hernia repair with tension free mesh

Nerve preservationNeurectomy
NeurectomyPROCEDURE

Neurectomy

Neurectomy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Hernia, InguinalChronic PainHypesthesia

Interventions

Denervation

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Martin Thurnheer, MD

    Department of Surgery, Cantonal Hospital St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

July 1, 2005

Primary Completion

March 1, 2011

Study Completion

September 1, 2011

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

CH(1)