IDEAL: Preoperative Staging of Endometriosis With MRI

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT01939535

Collaborator

(none)

120

Enrollment

Location

51.2

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

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 :

Sep 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Dec 7, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Odds of changed surgical approach in deep endometriosis based on preoperative MRI findings. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01939535

Other Study ID Numbers:

S54441

First Posted:

Sep 11, 2013

Last Update Posted:

Dec 8, 2017

Last Verified:

Nov 1, 2016

Keywords provided by Universitaire Ziekenhuizen Leuven

Endometriosis

Magnetic resonance imaging

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Dec 8, 2017