- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939535
Preoperative Staging of Endometriosis With MRI (IDEAL)
December 7, 2017 updated by: Universitaire Ziekenhuizen KU Leuven
Prospective Evaluation of the Value of Magnetic Resonance Imaging as a One-stop-shop for Preoperative Stratification of Patients With Complexe Endometriosis - Imaging Deep Endometriosis Assessment Versus Laparoscopy.
The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.
Study Overview
Detailed Description
The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing either a surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.
Study Type
Observational
Enrollment (Actual)
120
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
-
-
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Leuven, Belgium, 3000
- University Hospitals KULeuven
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women with endometriosis in a tertiary referral centre
Description
Inclusion Criteria:
- Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery
Exclusion Criteria:
- Contra-indications for MRI; claustrophobic patients; patients in bad condition; pregnancy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women with endometriosis
Women with endometriosis with the intention of surgery - no intervention
|
Evaluation of an imaging technique ic MRI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Odds of changed surgical approach in deep endometriosis based on preoperative MRI findings.
Time Frame: All the imaging findings will be checked during a laparoscopy the latest 80 weeks after the imaging examinations.
|
All endometriosis lesions found on MRI will be checked during laparoscopy in order to determine how the MRI findings might have changed the decision to do a surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons, and this compared to the conventional preoperative imaging approach (double contrast barium enema, intravenous urography and ultrasound.
|
All the imaging findings will be checked during a laparoscopy the latest 80 weeks after the imaging examinations.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Didier Bielen, PhD, University Hospitals KULeuven
- Principal Investigator: Elvier Mussen, MD, University Hospitals KULeuven
- Principal Investigator: Carla Tomassetti, MD, University Hospitals KULeuven
- Principal Investigator: Christel Meuleman, PhD, University Hospitals KULeuven
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
September 1, 2013
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 7, 2017
Study Registration Dates
First Submitted
June 27, 2013
First Submitted That Met QC Criteria
September 6, 2013
First Posted (Estimate)
September 11, 2013
Study Record Updates
Last Update Posted (Actual)
December 8, 2017
Last Update Submitted That Met QC Criteria
December 7, 2017
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S54441
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.
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