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Predicting absence of endometriosis in people with pelvic pain

Developing and evaluating a screening tool to improve pre-operative prediction of absence of endometriosis in people with pelvic pain

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000357853
Enrollment
666
Registered
2021-03-30
Start date
2021-04-19
Completion date
2024-09-01
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Endometriosis is an important and common cause for pelvic pain for which laparoscopy provides definitive diagnosis and often symptom relief. There are however many people with pelvic pain who do not have endometriosis in whom laparoscopy poses potential risks and costs without the same possibility for symptom benefit. As yet, there are no validated, symptom-based, patient-reported questionnaires for endometriosis screening. We plan to make a predictive tool that uses questions about a person’s symptoms and medical history and their anogenital distance (AGD – the distance from the vagina to the anus which is associated with chance of endometriosis), to better predict pre-operatively the absence of endometriosis. This could hopefully be used as a tool that women could use to help decide if they want to go on and have a laparoscopy or not. It might result in fewer women having unnecessary surgery and getting more appropriate treatment for their pain instead. In this study we will look at people already planning to have a laparoscopy for investigation of their pelvic pain. We will ask them to fill in a questionnaire about their symptoms and medical history before their operation and then we will check if they had endometriosis at surgery or not. We will also measure their anogenital distance while they are asleep under the anaesthetic for their surgery. We will use this information to develop and validate a predictive tool for absence of endometriosis.

Interventions

People planned to have laparoscopy for investigation and/or management of pelvic pain will complete a questionnaire about their demographics and symptoms. This will take approximately 20-25 minutes to complete. It will be completed pre-operatively from anytime once they are booked for surgery/placed on the surgical waiting list. Participants will have their anogenital distance measured once they are asleep under anaesthetic immediately prior to their surgery commencing, at the time of routine pr

People planned to have laparoscopy for investigation and/or management of pelvic pain will complete a questionnaire about their demographics and symptoms. This will take approximately 20-25 minutes to complete. It will be completed pre-operatively from anytime once they are booked for surgery/placed on the surgical waiting list. Participants will have their anogenital distance measured once they are asleep under anaesthetic immediately prior to their surgery commencing, at the time of routine pre-operative examination. It will take approximately 1 minute for the anogenital distance to be measured. At laparoscopy it will be documented if endometriosis is present or absent. Pre-operative variables collected will be used to create a predictive model for absence of endometriosis.

Sponsors

The Royal Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

• Women aged 18 – 45 planned to undergo laparoscopy for investigation and/or management of pelvic pain • Pelvic ultrasound performed within 12 months of recruitment with no evidence of endometrioma/s and/or deep infiltrating endometriosis o Both specialist quality and community quality ultrasound included • Women with a previous laparoscopy for investigation of pelvic pain and women with a previous diagnosis of endometriosis remain eligible • Women with both current and previous hormone use remain eligible

Exclusion criteria

• Unable to provide consent • Previous participation in the same study • Post-menopausal • Pelvic ultrasound showing another likely cause for pain that would independently warrant laparoscopy (eg evidence of tubo-ovarian abscess, hydrosalpinx, other ovarian cyst, fibroid warranting myomectomy). • Evidence on ultrasound of endometriosis (endometrioma or DIE) • Unable to obtain report of pelvic ultrasound

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026