- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01505686
MRI Findings in Inguinal Hernia
June 25, 2014 updated by: Sanna Kouhia, North Karelia Central Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Joensuu, Finland, FIN-80210
- North Karelia Central Hospital, department of surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age < 50 years
- painful inguinal hernia
Exclusion Criteria:
- conditions that do not allow the use of MRI
- conditions that prevent general anesthesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: study group
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.
|
MRI scan with a 1,5 T MRI scanner
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory changes in MRI scan
Time Frame: 7 months
|
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.
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores
Time Frame: 7 months
|
Preoperative and postoperative patient questionaires are used.
Preoperative values are examined to determine, if they can be used to predict postoperative pain problems.
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
January 4, 2012
First Submitted That Met QC Criteria
January 5, 2012
First Posted (ESTIMATE)
January 6, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 26, 2014
Last Update Submitted That Met QC Criteria
June 25, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NKCH-Surg-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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