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Preoperative Staging of Endometriosis With MRI (IDEAL)

This study is currently recruiting participants.
Verified October 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01939535
First received: June 27, 2013
Last updated: March 14, 2014
Last verified: October 2012
  Purpose

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 Intervention
Endometriosis
Other: No intervention

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women with endometriosis
Women with endometriosis with the intention of surgery - no intervention
Other: No intervention
Evaluation of an imaging technique ic MRI

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.

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01939535

Locations
Belgium
University Hospitals KULeuven Recruiting
Leuven, Belgium, 3000
Contact: Ingrid Fruyt    +3216343781    ingrid.fruyt@uzleuven.be   
Contact: Linda Meersman    +3216343782    linda.meersman@uzleuven.be   
Principal Investigator: Didier Bielen, PhD         
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
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01939535     History of Changes
Other Study ID Numbers: S54441
Study First Received: June 27, 2013
Last Updated: March 14, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Endometriosis
Magnetic resonance imaging

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014