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Preoperative Staging of Endometriosis With MRI (IDEAL)

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ClinicalTrials.gov Identifier: NCT01939535
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment
Endometriosis Other: No intervention

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
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.
Study Start Date : September 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Women with endometriosis
Women with endometriosis with the intention of surgery - no intervention
Other: No intervention
Evaluation of an imaging technique ic MRI




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with endometriosis in a tertiary referral centre
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939535


Locations
Belgium
University Hospitals KULeuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01939535     History of Changes
Other Study ID Numbers: S54441
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: November 2016

Keywords provided by Universitaire Ziekenhuizen Leuven:
Endometriosis
Magnetic resonance imaging

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female