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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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14 June 2021 |
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Main ID: |
ACTRN12621000682842 |
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Date of registration:
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04/06/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Royal Womens Hospital (RWH) anogenital distance in adult women undergoing gynaecological surgery study
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Scientific title:
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Royal Womens Hospital (RWH) anogenital distance in adult women undergoing gynaecological surgery study |
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Date of first enrolment:
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01/03/2021 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12621000682842.aspx |
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Study type:
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Observational |
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Study design:
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Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Thomas Kavanagh
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Address:
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Royal Women's Hospital
20 Flemington Rd
Parkville
Victoria 3052
Australia |
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Telephone:
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+61 383452000 |
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Email:
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tom.kavanagh@thewomens.org.au |
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Affiliation:
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Name:
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Dr Thomas Kavanagh
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Address:
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Royal Women's Hospital
20 Flemington Rd
Parkville
Victoria 3052
Australia |
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Telephone:
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+61 383452000 |
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Email:
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tom.kavanagh@thewomens.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All women aged 18 to 50 years undergoing gynaecological surgery, with general anaesthesia, under the care of Gynaecology 1, Gynaecology 2 and Acute gynaecology teams at The Royal Women’s Hospital in Melbourne will be eligible to be enrolled in this study.
Exclusion criteria: Unable to provide consent
Previous participation in the same study
Age less than 18 years or more than 50 years
Post-menopausal
Those undergoing surgery for an acute pathology that may alter the participant’s usual external gential anatomy (such as Bartholin’s Gland Abscess, Labial abscess or genital trauma)
Those with a history of previous vaginal surgery, such as prolapse repair or vulval surgery (such as treatment of vulval cancer).
Previous female genital mutilation
Those who are currently pregnant
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Endometriosis;Polycystic ovarian syndrome;Pelvic pain;
Endometriosis
Polycystic ovarian syndrome
Pelvic pain
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Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
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Intervention(s)
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Participants will complete the study questionnaire pre-operatively. The study questionnaire will be available electronically via online platform ‘SurveyMonkey’ and in hard copy form if requested.
The participants' anogenital distance (AGD) will be measured after they are anaesthetised, in the lithotomy position, by two of the treating team. It will be measured using disposable paper ruler. Two measurements will be taken. The AGD AC is the distance from the anus to the anterior part of the clitoral hood. The AGD AF is the distance from the anus to the posterior fourcette.
If the patient is undergoing a laparoscopy, the treating clinicians will be asked to note whether or not endometriosis is present.
The AGD will be measured again at the conclusion of the procedure.
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Primary Outcome(s)
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Compare the AGD AF (as measured with a disposable paper ruler in the lithotomy position) of participants with histologically proven endometriosis diagnosed at the procedure (endometriosis positive laparoscopy), to those without endometriosis (endometriosis negative laparoscopy)[Measurements will be taken during surgery and analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.]
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Determine the mean AGD AC (anterior anogenital distance) for the studied population as measured with a disposable paper ruler in the lithotomy position.[Measurements will be taken during surgery and analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.]
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Determine the mean AGD AF (posterior anogenital distance) for the studied population.as measured with a disposable paper ruler in the lithotomy position.[Measurements will be taken during surgery and analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.]
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Secondary Outcome(s)
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The determine the relationship, if any, between AGD measurements and participant BMI. [A participant questionnaire will be completed prior to surgery. Measurements will be taken during surgery. Data will analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.]
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To determine the relationship, if any, between AGD measurements and a previous diagnosis of PCOS, as reported by the participant[A participant questionnaire will be completed prior to surgery. Measurements will be taken during surgery. Data will analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.]
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To determine the relationship, if any, between AGD measurements and parity, as reported by the participant.[A participant questionnaire will be completed prior to surgery. Measurements will be taken during surgery. Data will analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.]
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Source(s) of Monetary Support
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Royal Women's Hospital Gynaecology 2 Unit
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Ethics review
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Status: Approved
Approval date: 08/02/2021
Contact:
Royal Womens Hospital HREC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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