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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04171297
Registration number
NCT04171297
Ethics application status
Date submitted
18/11/2019
Date registered
20/11/2019
Date last updated
8/05/2024
Titles & IDs
Public title
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
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Scientific title
Ultrasound Evaluation of the Pelvis Using the International Deep Endometriosis Analysis (IDEA) Terminology in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery - IDEA 1 Study
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Secondary ID [1]
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S63056
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Universal Trial Number (UTN)
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Trial acronym
IDEA1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gynecologic Disease
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Endometriosis
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Endometriosis, Rectum
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Endometriosis of Colon
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Endometriosis of Vagina
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Endometriosis Rectovaginal Septum
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Endometriosis of Bladder
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Surgery
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Condition category
Condition code
Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
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0
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Menstruation and menopause
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Ultrasound evaluation of DE
Treatment: Surgery: Ultrasound evaluation of DE
To evaluate diagnostic accuracy of ultrasound for the presence of deep endometriosis.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Presence of deep endometriosis
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Assessment method [1]
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The primary objective is to assess the diagnostic value of the ultrasound features in the diagnosis of deep endometriosis. The endpoints are the univariable diagnostic accuracies of ultrasound features (defined by the IDEA consensus statement) for the presence of deep endometriosis at any location: anterior compartment (i.e. bladder and its specific location) or posterior compartment (i.e. rectovaginal septum, uterosacral ligaments, torus uterinus, vaginal fornix and bowel involvement). All recruited patients are included in this analysis. The reference standard for this objective is whether there is deep endometriosis (at any location) or not (binary outcome).
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Timepoint [1]
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1 year
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Eligibility
Key inclusion criteria
- Patients scheduled for radical laparoscopic endometriosis surgery
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- <18 years
- >45 years
- (suspected) Pelvic malignancy for example gynecological, intestinal or urological
malignancy
- Premenarche
- Menopause
- Pregnancy
- Patients refusal for radical surgery (for example refusal for bowel
resection/temporary stoma)
- Surgery performed more than 1 year after ultrasound scan
- Patients refusal to participate to the study
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sydney Medical School Nepean - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Leuven
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Country [2]
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Italy
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State/province [2]
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Cagliari
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Funding & Sponsors
Primary sponsor type
Other
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Name
Universitaire Ziekenhuizen KU Leuven
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Cagliari
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
An international multicenter observation study to evaluate the diagnostic accuracy and
predictive value of ultrasound using the IDEA terminology in the detection of deep
endometriosis in women scheduled for surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04171297
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dirk Timmerman, MD, PhD
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Address
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UZ Leuven
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04171297
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