Inguinal HerniaNCT01505686
MRI Findings in Inguinal Hernia
A study testing MRI scan in people with Inguinal Hernia and Pain, run by North Karelia Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Inguinal Hernia, Pain
- What is being tested?
- MRI scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFinland
- Study dates
- May 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age < 50 years
- painful inguinal hernia
Who cannot join
- conditions that do not allow the use of MRI
- conditions that prevent general anesthesia
Trial locations and contacts
1 site in 1 country.
Finland1 site
North Karelia Central Hospital, department of surgery
Joensuu, FIN-80210
About this study
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.
- Conditions
- Inguinal Hernia, Pain
- Being tested
- MRI scan
- Medical subject headings
- Hernia, Inguinal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanProcedure or surgery
MRI scan with a 1,5 T MRI scanner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (1)
Pain scores
Preoperative and postoperative patient questionaires are used. Preoperative values are examined to determine, if they can be used to predict postoperative pain problems.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Kouhia, North Karelia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505686
- Sponsor's protocol ID
- NKCH-Surg-008
- Status last verified
- Jun 2014
- First submitted
- 4 Jan 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Findings in Inguinal Hernia
- ClinicalTrials.gov ID
- NCT01505686
- Acronym / sponsor ID
- NKCH-Surg-008
- Conditions
- Inguinal Hernia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: MRI scanAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age < 50 years
- painful inguinal hernia
Key exclusion criteria (2 listed)
- conditions that do not allow the use of MRI
- conditions that prevent general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanMRI scan with a 1,5 T MRI scanner | Procedure or surgery | study group |
Primary outcome
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.
1 secondary outcome
Pain scores
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Inguinal Hernia and Pain, run by North Karelia Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory changes in MRI scan (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.