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

Status

Completed

Conditions

Intervention / Treatment

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

      • 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

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.

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

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.

Clinical Trials on Pain

Clinical Trials on MRI scan

3
Subscribe