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MRI Findings in Inguinal Hernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01505686
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Pain Procedure: MRI scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Findings in Inguinal Hernia
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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.
Procedure: MRI scan
MRI scan with a 1,5 T MRI scanner

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age < 50 years
  • painful inguinal hernia

Exclusion Criteria:

  • conditions that do not allow the use of MRI
  • conditions that prevent general anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01505686

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North Karelia Central Hospital, department of surgery
Joensuu, Finland, FIN-80210
Sponsors and Collaborators
North Karelia Central Hospital
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Responsible Party: Sanna Kouhia, Principal investigator, North Karelia Central Hospital Identifier: NCT01505686    
Other Study ID Numbers: NKCH-Surg-008
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal