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Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00500214
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : July 12, 2007
Information provided by:

Study Description
Brief Summary:
this study was designed to evaluate the effect of routine excision of the ilioinguinal nerve in an attempt to decrease the incidence of chronic inguinodynia in patients who undergo open anterior hernia mesh repair.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Hyposthesia Procedure: elective ilioinguinal nerve excision Phase 2

Detailed Description:
As chronic pain is the 2nd most common complication following open hernia repairs and it causes limitations and dysfunctions for the patients and also according to some previous studies elective ilioinguinal neurectomy could result in less postoperative pain,we decided to perform a randomized double blind clinical trial.The primary goal of this study was evaluation of the effect of this type of neurectomy on postoperative pain and hyposthesia.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : April 2005
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. postoperative pain using VAS (visual analogue scale) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. postoperative hyposthesia using VAS (visual analogue scale) [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • having an age of over 18 years

Exclusion Criteria:

  • Those with diabetes, incarcerated, bilateral and recurrent hernias and visual problems were excluded from the investigation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500214

Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: fatemeh malekpour, MD Shahid Beheshti University of Medical Sciences
More Information

ClinicalTrials.gov Identifier: NCT00500214     History of Changes
Other Study ID Numbers: Ilioinguinal nerve excision
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: July 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
inguinal hernia
mesh repair
ilioinguinal neurectomy
postoperative pain in cases and controls during one year.
postoperative hyposthesia in cases and controls during one year.

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms