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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00500214
First received: July 10, 2007
Last updated: July 11, 2007
Last verified: July 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Shahid 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

Keywords provided by Shahid 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.

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014