ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

endometriosis

Condition category

Condition code

Reproductive Health and Childbirth

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]

Diagnosis / Prognosis

Comparator / control treatment

Surgical findings were the comparator

Control group

Active

Outcomes

Primary outcome [1]

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]

2012-2015

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Mercy Hospital for Women - Heidelberg

Recruitment hospital [2]

Epworth Freemasons - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mercy Hospital for Women

Address [1]

Mercy Hospital for Women
163 Studley Road, Heidelberg, Vic 3084

Country [1]

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]

Hospital

Name [1]

Mercy Hospital for Women Heidelberg

Address [1]

163 Studley Road, Heidelberg, Vic 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Health Human Research Ethics Committe

Ethics committee address [1]

163 Studley Road, Heidelberg, Vic 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/02/2016

Approval date [1]

03/03/2016

Ethics approval number [1]

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

Dr Prathima Chowdary

Address

Mercy Hospital for Women
163 Studley Road, Heidelberg, Vic 3084

Country

Australia

Phone

+61470433777

Fax

prath1mak@yahoo.co.in

Contact person for public queries

Name

Prathima Chowdary

Address

Mercy hospital for Women
163 Studley Road, Heidelberg, Vic 3084

Country

Australia

Phone

+61470433777

Fax

prath1mak@yahoo.co.in

Contact person for scientific queries

Name

Prathima Chowdary

Address

Mercy hospital for Women
163 Studley Road, Heidelberg, Vic 3084

Country

Australia

Phone

+61470433777

Fax

prath1mak@yahoo.co.in

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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