EndometriosisIDEALNCT01939535
Preoperative Staging of Endometriosis With MRI
An observational study of Endometriosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to 7 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with endometriosis in a tertiary referral centre
Who may be able to join
- Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery
Who cannot join
- Contra-indications for MRI; claustrophobic patients; patients in bad condition; pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- No intervention
- Keywords
- Endometriosis, Magnetic resonance imaging
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Evaluation of an imaging technique ic MRI
| Study group | Role | What they receive |
|---|---|---|
| Women with endometriosis | Women with endometriosis with the intention of surgery - no intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All the imaging findings will be checked during a laparoscopy the latest 80 weeks after the imaging examinations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Bielen, PhD, Principal investigator, University Hospitals KULeuvenElvier Mussen, MD, Principal investigator, University Hospitals KULeuvenCarla Tomassetti, MD, Principal investigator, University Hospitals KULeuvenChristel Meuleman, PhD, Principal investigator, University Hospitals KULeuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939535
- Sponsor's protocol ID
- S54441
- Acronym
- IDEAL
- Status last verified
- Nov 2016
- First submitted
- 27 Jun 2013
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01939535
- Acronym / sponsor ID
- IDEAL / S54441
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with endometriosis | – | Other: No interventionWomen with endometriosis with the intention of surgery - no intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with endometriosis in a tertiary referral centre
Key inclusion criteria (1 listed)
- Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery
Key exclusion criteria (1 listed)
- Contra-indications for MRI; claustrophobic patients; patients in bad condition; pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionEvaluation of an imaging technique ic MRI | Other | Women with endometriosis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Bielen, PhD principal investigator
University Hospitals KULeuven
Elvier Mussen, MD principal investigator
University Hospitals KULeuven
Carla Tomassetti, MD principal investigator
University Hospitals KULeuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.