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OpenTrials
Completed

NCT Number: NCT01939535

Preoperative Staging of Endometriosis With MRI

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.

Completed

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals KULeuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Evaluation of an imaging technique ic MRI

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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.

Acronym: IDEAL

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 11, 2013
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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