Preoperative Staging of Endometriosis With MRI

Endometriosis Clinical Trial

— IDEAL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939535
• Other study ID #: S54441
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: December 7, 2017
• Start date: September 2013
• Est. completion date: December 7, 2017

Study information

• Verified date: November 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 7, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• No intervention
Evaluation of an imaging technique ic MRI

Locations

Country	Name	City	State
Belgium	University Hospitals KULeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds of changed surgical approach in deep endometriosis based on preoperative MRI findings.	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.	All the imaging findings will be checked during a laparoscopy the latest 80 weeks after the imaging examinations.