NCT01505686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.6 years

First QC Date

January 4, 2012

Last Update Submit

June 25, 2014

Conditions

Inguinal HerniaPain

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 months

Secondary Outcomes (1)

  • Pain scores

    7 months

Study Arms (1)

study group

EXPERIMENTAL

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

Interventions

MRI scanPROCEDURE

MRI scan with a 1,5 T MRI scanner

study group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age \< 50 years
  • painful inguinal hernia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Karelia Central Hospital, department of surgery

Joensuu, FIN-80210, Finland

Location

MeSH Terms

Conditions

Hernia, InguinalPain

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

FI(1)