Preoperative Staging of Endometriosis With MRI
IDEAL
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.
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2017
CompletedDecember 8, 2017
November 1, 2016
3 years
June 27, 2013
December 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Odds of changed surgical approach in deep endometriosis based on preoperative MRI findings.
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.
Study Arms (1)
Women with endometriosis
Women with endometriosis with the intention of surgery - no intervention
Interventions
Eligibility Criteria
Women with endometriosis in a tertiary referral centre
You may qualify if:
- Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery
You may not qualify if:
- Contra-indications for MRI; claustrophobic patients; patients in bad condition; pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals KULeuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2013
First Posted
September 11, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2016
Study Completion
December 7, 2017
Last Updated
December 8, 2017
Record last verified: 2016-11