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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
S63056
Universal Trial Number (UTN)
Trial acronym
IDEA1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynecologic Disease 0 0
Endometriosis 0 0
Endometriosis, Rectum 0 0
Endometriosis of Colon 0 0
Endometriosis of Vagina 0 0
Endometriosis Rectovaginal Septum 0 0
Endometriosis of Bladder 0 0
Surgery 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of deep endometriosis
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* Patients scheduled for radical laparoscopic endometriosis surgery
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Medical School Nepean - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Italy
State/province [2] 0 0
Cagliari

Funding & Sponsors
Primary sponsor type
Other
Name
Universitaire Ziekenhuizen KU Leuven
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Cagliari
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04171297
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dirk Timmerman, MD, PhD
Address 0 0
UZ Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04171297