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Trial registered on ANZCTR


Registration number
ACTRN12621001324808
Ethics application status
Approved
Date submitted
21/08/2021
Date registered
29/09/2021
Date last updated
29/09/2021
Date data sharing statement initially provided
29/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Uterosacral ligament thickness: a novel ultrasound measurement for diagnosing endometriosis
Scientific title
Ultrasound assessment of the uterosacral ligaments and diagnostic accuracy for peritoneal endometriosis: A pilot single-centre prospective study.
Secondary ID [1] 304491 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 323329 0
Condition category
Condition code
Reproductive Health and Childbirth 320890 320890 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants will complete a transvaginal ultrasound within 8 weeks prior to the planned laparoscopy (laparoscopy planned independent of the study). The ultrasound will take approximately 15minutes.
-- All findings of deep endometriosis will be reported to the managing surgical teams, along with any other sinister pathological concerns. The additional assessment on pelvic ultrasound will include a measurement (in mm) of both USLs. This will be completed in an axial plane at the level of the internal cervical os, 10 mm from the medial insertion of the ligament. The measurement will include the lipomatous layer of the USL in this plane and will exclude the vascular and neural components of the ligament. In addition to this objective measurement, the mobility of the USLs, tenderness of the USLs and tenderness of the pelvic floor muscles will be dichotomised and recorded as yes/no. The USL measurements will not be reported to the managing clinicians. The assessment of the USL is not included in the current ASUM reporting guidelines for pelvic imaging.

On the same day as the ultrasound, a 15minute questionnaire will be completed by the participant.

All participants will undergo their scheduled laparoscopic pelvic surgery, as was planned irrespective of study involvement. The surgeon will capture standardised clinical pictures, plus additional pictures of visible disease. The surgeon will then take the standardised biopsies of each USL. These biopsies are to be taken at a standardized point (10mm from the medial insertion) and be of a size at least 10mm x 3mmThe surgery will then be completed with excision of other visible disease. The surgeon will complete a 5minute form describing the surgical findings.

Histological specimens will be processed in the standard way by two anatomical pathologists.
Intervention code [1] 321498 0
Diagnosis / Prognosis
Comparator / control treatment
Two groups of participants will form this prospective cohort study.
(1) study group will include participants booked for laparoscopy with a history of pelvic pain, dysmenorrhea, or infertility - these patients have a 30-50% chance of endometriosis
(2) a 'control' group will consist of participants who are booked for laparoscopy for another indication, eg fibroids, simple ovarian cyst, tubal sterilisation procedures - these patients have a 10% chance of endometriosis
Control group
Active

Outcomes
Primary outcome [1] 328684 0
What is the accuracy of ultrasound measurement of uterosacral ligament thickness (cm) as a marker of peritoneal endometriosis? This will be determined by comparing results of USL thickness on ultrasound with histological assessment of the USL biopsy, and histological of any other peritoneal excisions (if taken).
Timepoint [1] 328684 0
Histological assessment within 8weeks of the ultrasound assessment.
Secondary outcome [1] 399956 0
Presence of uterosacral tenderness on pelvic ultrasound and it's usage as a marker for peritoneal endometriosis. This will be determined by comparing results of USL tenderness on ultrasound with histological assessment of the USL biopsy, and histological of any other peritoneal excisions (if taken).and uterosacral mobility and peritoneal endometriosis
Timepoint [1] 399956 0
Histological assessment within 8 weeks of the ultrasound assessment.
Secondary outcome [2] 400786 0
Presence of uterosacral mobility on pelvic ultrasound and it's usage as a marker for peritoneal endometriosis. This will be determined by comparing results of USL mobility on ultrasound with histological assessment of the USL biopsy, and histological of any other peritoneal excisions (if taken).and uterosacral mobility and peritoneal endometriosis
Timepoint [2] 400786 0
Histological assessment within 8 weeks of the ultrasound assessment.

Eligibility
Key inclusion criteria
Inclusion Criteria (high-risk cohort):
1. Age 18yrs and older
2. Pre-menopausal
3. Women with pain and/or infertility
4. Women waitlisted for laparoscopy +/- treatment of endometriosis

Inclusion Criteria (low-risk cohort):
1. Age 18yrs and older
2. Pre-menopausal
3. Booked for laparoscopy for an indication other than pelvic pain and/or infertility
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior laparoscopy and treatment of endometriosis
2. Post-menopausal
3. Prior hysterectomy
4. Prior imaging evidence of grade III/IV endometriosis
5. Diagnosis on pre-operative ultrasound of endometrioma or deep endometriosis
6. Not consenting to transvaginal pelvic ultrasound
7. Non-english speaking

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Cohort characteristics will be summarized as mean (SD), median [25th – 75th percentile] or number (%) according to data type and distribution.
The outcome, histologically proven endometriosis involving the left or right uterosacral ligaments, is considered to be measured without error. The aim is to assess the association of ultrasound measured left and right uterosacral ligament thickness (USLT) with this outcome. USLT will be treated as a continuous covariate and modelled both unadjusted and adjusted for patient BMI, age and hormonal suppression (possibly other covariates) in a logistic linear model. Modelling will assess linearity of the association and may use polynomial terms, splines or other flexible techniques to capture the relationship. Uterine ligament samples are paired within patients and this within subject correlation will be accounted for using a marginal mean model estimated by generalized estimating equations (GEE).

If an association between outcome and USLT is established then a predictive regression model will be developed. Given that model identification and internal validation use the same data set 10-fold cross validation of the predictive model will be used to attenuate regression coefficients and reduce both overfitting and overly optimistic estimates of predictive ability. Routine predictive model diagnostics will be performed including (i) calibration (mean predictive ability and assessment of slope and intercept of linear predictor against outcome); (ii) discrimination (area under ROC curve), (iii) sensitivity at 80 & 90% specificity and (iv) negative and positive predictive value for a range of prevalence likely to be found in clinical practice. At prespecified specificity (80 or 90%) a joint confidence region will be defined and used to determine 95% confidence limits at that specificity for the model/data determined sensitivity.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/07/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
28/02/2022
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20310 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 35052 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 308853 0
University
Name [1] 308853 0
University of Melbourne
Country [1] 308853 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 309769 0
None
Name [1] 309769 0
Address [1] 309769 0
Country [1] 309769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308760 0
Mercy Hospital For Women
Ethics committee address [1] 308760 0
Ethics committee country [1] 308760 0
Australia
Date submitted for ethics approval [1] 308760 0
Approval date [1] 308760 0
30/07/2020
Ethics approval number [1] 308760 0
MHW HREC 2019-028

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111794 0
Dr Kate Stone
Address 111794 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 111794 0
Australia
Phone 111794 0
+61384584300
Fax 111794 0
Email 111794 0
katestonemail@icloud.com
Contact person for public queries
Name 111795 0
Samantha Mooney
Address 111795 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 111795 0
Australia
Phone 111795 0
+61384584444
Fax 111795 0
Email 111795 0
samantha.mooney39@gmail.com
Contact person for scientific queries
Name 111796 0
Samantha Mooney
Address 111796 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 111796 0
Australia
Phone 111796 0
+61384584444
Fax 111796 0
Email 111796 0
samantha.mooney39@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.