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MRI Findings in Inguinal Hernia

This study is currently recruiting participants.
Verified December 2012 by North Karelia Central Hospital
Sponsor:
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital
ClinicalTrials.gov Identifier:
NCT01505686
First received: January 4, 2012
Last updated: December 1, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Inguinal Hernia
Pain
 Procedure: MRI scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI Findings in Inguinal Hernia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • Inflammatory changes in MRI scan [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Preoperative and postoperative patient questionaires are used. Preoperative values are examined to determine, if they can be used to predict postoperative pain problems.


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505686

Contacts
Contact: Sanna Kouhia, MD +358-50-4353882 sanna.kouhia@pkssk.fi

Locations
Finland
North Karelia Central Hospital, department of surgery Recruiting
Joensuu, Finland, FIN-80210
Contact: Sanna Kouhia, MD     +358-50-4353882     sanna.kouhia@pkssk.fi    
Principal Investigator: Sanna Kouhia, MD            
Sponsors and Collaborators
North Karelia Central Hospital
  More Information

No publications provided

Responsible Party: Sanna Kouhia, Principal investigator, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01505686     History of Changes
Other Study ID Numbers: NKCH-Surg-008
Study First Received: January 4, 2012
Last Updated: December 1, 2012
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 23, 2013