Back to resultsNeurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neurectomy in inguinal hernia repair
nerve sparing in inguinal hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- patients male, and age between 20 to 70 years Reducible inguinal hernia
Exclusion Criteria:
- Irreducible, obstructed or strangulated hernia uncontrolled diabetes
Sites / Locations
- Services Hospital Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Neurectomy
Nerve Sparing
Arm Description
In this group we did mesh hernioplasty of inguinal hernia with neurectomy of iliohypogastric and ilioinguinal nerve
In this group we did mesh hernioplasty of inguinal hernia with preservation of iliohypogastric and ilioinguinal nerve
Outcomes
Primary Outcome Measures
percentage of patients developing chronic inguinodynia
Excruciating Pain measured by visual analog score (with 1 being minimum score and 10 being maximum score) for more than 3 months in inguinal region after open mesh hernioplasty for inguinal hernia
Secondary Outcome Measures
Full Information
NCT ID
NCT03765268
First Posted
July 13, 2018
Last Updated
February 2, 2019
Sponsor
Services Hospital, Lahore
1. Study Identification
Unique Protocol Identification Number
NCT03765268
Brief Title
Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Official Title
Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It is a randomized controlled trial in which we are treating inguinal hernia patients with mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy or preservation comparing post operative acute or chronic pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurectomy
Arm Type
Active Comparator
Arm Description
In this group we did mesh hernioplasty of inguinal hernia with neurectomy of iliohypogastric and ilioinguinal nerve
Arm Title
Nerve Sparing
Arm Type
Active Comparator
Arm Description
In this group we did mesh hernioplasty of inguinal hernia with preservation of iliohypogastric and ilioinguinal nerve
Intervention Type
Procedure
Intervention Name(s)
Neurectomy in inguinal hernia repair
Intervention Description
Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve
Intervention Type
Procedure
Intervention Name(s)
nerve sparing in inguinal hernia repair
Intervention Description
Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve
Primary Outcome Measure Information:
Title
percentage of patients developing chronic inguinodynia
Description
Excruciating Pain measured by visual analog score (with 1 being minimum score and 10 being maximum score) for more than 3 months in inguinal region after open mesh hernioplasty for inguinal hernia
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients male, and age between 20 to 70 years Reducible inguinal hernia
Exclusion Criteria:
Irreducible, obstructed or strangulated hernia uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmmood Ayyaz, mbbs, fcps
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
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