Elective Neurectomy During Inguinal Hernia Repair | NCT00492804

Studies
Elective Neurectomy During Inguinal Hernia Repair

NCT00492804

Sponsor

Cantonal Hospital of St. Gallen

Status

Completed

Last Update Posted

Jan 28, 2013Estimated

Enrollment

200Actual

Phase

Phase 2

Conditions

Inguinal Hernia

Interventions

Lichtenstein hernia repair
Neurectomy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Mar 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 26, 2007

First Posted Date

Jun 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neurectomy	Other		Procedure: Lichtenstein hernia repair Procedure: Neurectomy
Nerve preservation	Other		Procedure: Lichtenstein hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lichtenstein hernia repair	Procedure	Lichtenstein hernia repair with tension free mesh	Nerve preservation Neurectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative pain		up to three years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of hypesthesia or paraesthesia		one and three years
Recurrence rate		one and three years
Rate of intra- and postoperative complications

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Thurnheer, MD	Department of Surgery, Cantonal Hospital St. Gallen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Cantonal Hospital of St. Gallen		Sankt Gallen	Canton of St. Gallen	9007	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D059350	Chronic Pain
D006987	Hypesthesia

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003714	Denervation

Ancestor Terms

ID	Term
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided