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Clinical Trials/NCT01939535
NCT01939535
Completed
Not Applicable

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.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country120 target enrollmentSeptember 2013
ConditionsEndometriosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
120
Locations
1
Primary Endpoint
Odds of changed surgical approach in deep endometriosis based on preoperative MRI findings.
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 7, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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