Back to resultsIlioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial
Primary Purpose
Postoperative Pain, Postoperative Hyposthesia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
elective ilioinguinal nerve excision
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring 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.
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
postoperative pain using VAS (visual analogue scale)
Secondary Outcome Measures
postoperative hyposthesia using VAS (visual analogue scale)
Full Information
NCT ID
NCT00500214
First Posted
July 10, 2007
Last Updated
July 11, 2007
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00500214
Brief Title
Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Hyposthesia
Keywords
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.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
elective ilioinguinal nerve excision
Primary Outcome Measure Information:
Title
postoperative pain using VAS (visual analogue scale)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
postoperative hyposthesia using VAS (visual analogue scale)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatemeh malekpour, MD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ilioinguinal Nerve Excision in Open Mesh Repair of Inguinal Hernia,a Randomized Clinical Trial
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