Preoperative Staging of Endometriosis With MRI

Completed

• Conditions: Endometriosis
• Interventions: Other: No intervention

• Registration Number: NCT01939535
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

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 Timeline

• Study First Submitted: 2013-06-27
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-11
• Primary Completion: 2016-09
• Status Verified: 2016-11
• Study Completion: 2017-12-07
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with endometriosis	No intervention	Women with endometriosis with the intention of surgery - no intervention

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospitals KULeuven; 🇧🇪 Leuven, Belgium