Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial - Full Text View

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00500214

Purpose

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	Intervention	Phase
Postoperative Pain Postoperative Hyposthesia	Procedure: elective ilioinguinal nerve excision	Phase II

MedlinePlus related topics: Hernia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Study Start Date:	April 2005
Study Completion Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500214

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

fatemeh malekpour, MD

Shaheed Beheshti Medical University

More Information

Study ID Numbers:	Ilioinguinal nerve excision
Study First Received:	July 10, 2007
Last Updated:	July 11, 2007
ClinicalTrials.gov Identifier:	NCT00500214
Health Authority:	Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:

inguinal hernia
herniorrhaphy
mesh repair

ilioinguinal neurectomy
postoperative pain in cases and controls during one year.
postoperative hyposthesia in cases and controls during one year.

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Signs and Symptoms
Postoperative Complications
Hernia

Hernia, Abdominal
Pain
Hernia, Inguinal
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009