Back to resultsMRI Findings in Inguinal Hernia
Primary Purpose
Inguinal Hernia, Pain
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
MRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- age < 50 years
- painful inguinal hernia
Exclusion Criteria:
- conditions that do not allow the use of MRI
- conditions that prevent general anesthesia
Sites / Locations
- North Karelia Central Hospital, department of surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
All patients in this study have MRI scan prior to hernia repair surgery. If inflammatory changes are present, the scan is repeated 6 months after surgery. If not, the scan is performed only if the patient has pain problems at 6 months.
Outcomes
Primary Outcome Measures
Inflammatory changes in MRI scan
MRI scan is performed preoperatively and 6 months postoperatively to find possible inflammatory changes in the inguinal area, and the changes that a hernia mesh repair causes. If preoperative MRI scan does not have inflammatory changes, 6-month-MRI is only performed on-demand (if the patient is experiencing prolonged pain.
Secondary Outcome Measures
Pain scores
Preoperative and postoperative patient questionaires are used. Preoperative values are examined to determine, if they can be used to predict postoperative pain problems.
Full Information
NCT ID
NCT01505686
First Posted
January 4, 2012
Last Updated
June 25, 2014
Sponsor
North Karelia Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01505686
Brief Title
MRI Findings in Inguinal Hernia
Official Title
MRI Findings in Inguinal Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Karelia Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The aim of the present study is to determine, whether similar inflammatory changes can be detected with MRI scan in inguinal hernia. Also, patient questionaires are used preoperatively and postoperatively to determine, if preoperative pain scores can be used as a predictive value for postoperative prolonged pain/neuralgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
All patients in this study have MRI scan prior to hernia repair surgery. If inflammatory changes are present, the scan is repeated 6 months after surgery. If not, the scan is performed only if the patient has pain problems at 6 months.
Intervention Type
Procedure
Intervention Name(s)
MRI scan
Intervention Description
MRI scan with a 1,5 T MRI scanner
Primary Outcome Measure Information:
Title
Inflammatory changes in MRI scan
Description
MRI scan is performed preoperatively and 6 months postoperatively to find possible inflammatory changes in the inguinal area, and the changes that a hernia mesh repair causes. If preoperative MRI scan does not have inflammatory changes, 6-month-MRI is only performed on-demand (if the patient is experiencing prolonged pain.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Pain scores
Description
Preoperative and postoperative patient questionaires are used. Preoperative values are examined to determine, if they can be used to predict postoperative pain problems.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age < 50 years
painful inguinal hernia
Exclusion Criteria:
conditions that do not allow the use of MRI
conditions that prevent general anesthesia
Facility Information:
Facility Name
North Karelia Central Hospital, department of surgery
City
Joensuu
ZIP/Postal Code
FIN-80210
Country
Finland
12. IPD Sharing Statement
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MRI Findings in Inguinal Hernia
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