Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001106426
Ethics application status
Approved
Date submitted
9/05/2016
Date registered
16/08/2016
Date last updated
16/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicentre retrospective study to assess diagnostic accuracy of ultrasound for superficial endometriosis – are we any closer?
Scientific title
Multicentre retrospective study to assess diagnostic accuracy of ultrasound for superficial endometriosis – are we any closer?
Secondary ID [1] 289157 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometriosis 299055 0
Condition category
Condition code
Reproductive Health and Childbirth 299095 299095 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
Reviewing analysis of ultrasound data and surgical records in al patients undergoing a diagnostic ultrasound followed by surgery for endometriosis between January 2012 and Decemeber 2015 with no prospective follow up.
Intervention code [1] 294682 0
Diagnosis / Prognosis
Comparator / control treatment
Surgical findings were the comparator
Control group
Active

Outcomes
Primary outcome [1] 298225 0
Accuracy(sensitivity and specificity) of ultrasound scan as a tool for early detection of superficial endometriosis by correlation with surgical findings of endometriosis from medical record review
Timepoint [1] 298225 0
2012-2015
Secondary outcome [1] 323581 0
By retrospective review of the ultrasound scan and surgical records. Ultrasound scan findings which correlated best with operative findings - uterosacral thickness, thickened peri colic fat, ovarian immobility, assessed by review of the ultrasound scan and surgical records.
Timepoint [1] 323581 0
2012-2015

Eligibility
Key inclusion criteria
Received both a pre-surgical ultrasound scan by Kate Stone and a laparoscopy by an advanced endometriosis surgeon for superficial endometriosis between January 2012 and Decemeber 2015
Minimum age
17 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Deep endometriosis
Rectal involvment
Adenomyosis
Endometriomas

Study design
Purpose
Screening
Duration
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
No calculation was performed to calculate size, power or level of statistical significance. All records of patients scanned by one COGU consultant and Laparosocpy by endosurgiens were reviewed. Descriptive statistics were used to summarise all variables. Continuous variables were described as mean and standard deviation. Categorical variables were described as frequency and percentage. The proportion of patients who had laparoscopic findings consistent with their ultrasound findings was estimated with 95% confidence interval. Difference in BMI and age between patients with positive and negative findings were tested using the analysis of variance. Standard diagnostic and agreement statistics were calculated to assess the predictive effects of individual soft marker and symptom on operation findings. Sensitivity, specificity and ROC curve were estimated. All statistical tests were two-sided at 5% significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2016
Date of last participant enrolment
Anticipated
Actual
14/04/2016
Date of last data collection
Anticipated
24/03/2016
Actual
21/04/2016
Sample size
Target
50
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5753 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 5754 0
Epworth Freemasons - Melbourne

Funding & Sponsors
Funding source category [1] 293548 0
Hospital
Name [1] 293548 0
Mercy Hospital for Women
Country [1] 293548 0
Australia
Primary sponsor type
Individual
Name
Prathima Chowdary
Address
Mercy Hospital for Women,
163 Studley Road, Heidelberg, Vic 3084
Country
Australia
Secondary sponsor category [1] 292359 0
Hospital
Name [1] 292359 0
Mercy Hospital for Women Heidelberg
Address [1] 292359 0
163 Studley Road, Heidelberg, Vic 3084
Country [1] 292359 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294987 0
Mercy Health Human Research Ethics Committe
Ethics committee address [1] 294987 0
163 Studley Road, Heidelberg, Vic 3084
Ethics committee country [1] 294987 0
Australia
Date submitted for ethics approval [1] 294987 0
10/02/2016
Approval date [1] 294987 0
03/03/2016
Ethics approval number [1] 294987 0
R16/12

Summary
Brief summary
Clinical histories of 83 patients who had laparoscopy to investigate pelvic pain were reviewed. Laparoscopies were performed at Mercy Hospital for Women, Epworth Freemasons by surgeons trained in advanced laparoscopy and currently work in a tertiary endometriosis surgical unit. Patients with deep infiltrative endometriosis or non- endometriosis pelvic pathology on either MRI or ultrasound were excluded from the study. Ultrasounds were performed by a single sonologist with expertise in endometriosis assessments between 2012 – 2015. The ultrasound findings were dividing into sub groups as follows – presence of a utero sacral ligament nodule of endometriosis, utero sacral ligament thickness, thickened peri colic fat, ovarian mobility and focal tenderness. This was compared with operative findings of those patients with superficial endometriosis. Other parameters collected were age, BMI and symptoms –dysmenorrhoea, dyschezia, dysuria and dyspareunia. Standard diagnostic and agreement statistics were calculated to assess the predictive effects of individual ultrasound markers and symptoms on operation findings.
Endometriosis is a complex and heterogeneous condition. There is an increased incidence in women with pelvic pain and subfertility. Appropriate early triage for these patients has been shown to improve outcomes. There are no specific non-invasive methods of diagnosing superficial forms of endometriosis, whilst the ability to reliably detect deep infiltrative endometriosis on ultrasound is well established.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65682 0
Dr Prathima Chowdary
Address 65682 0
Mercy Hospital for Women
163 Studley Road, Heidelberg, Vic 3084
Country 65682 0
Australia
Phone 65682 0
+61470433777
Fax 65682 0
Email 65682 0
[email protected]
Contact person for public queries
Name 65683 0
Dr Prathima Chowdary
Address 65683 0
Mercy hospital for Women
163 Studley Road, Heidelberg, Vic 3084
Country 65683 0
Australia
Phone 65683 0
+61470433777
Fax 65683 0
Email 65683 0
[email protected]
Contact person for scientific queries
Name 65684 0
Dr Prathima Chowdary
Address 65684 0
Mercy hospital for Women
163 Studley Road, Heidelberg, Vic 3084
Country 65684 0
Australia
Phone 65684 0
+61470433777
Fax 65684 0
Email 65684 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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