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Comparison of two ultrasound assessment tools for the diagnosis of ovarian tumours in asymptomatic post-menopausal women

Comparison of intervention rates for the Risk of Malignancy Index (RMI) and the Royal College of Obstetricians and Gynaecologists green top guideline number 34 (October 2003) on postmenopausal cysts with simple ultrasound scan rules by the International Ovarian Tumour Analysis Group (IOTA): a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89034131
Enrollment
148
Registered
2012-03-30
Start date
2011-04-01
Completion date
Unknown
Last updated
2020-10-12

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

Conditions

Asymptomatic ovarian cysts or adnexal tumours in postmenopausal women Cancer Other and unspecified ovarian cysts

Interventions

Women with presumed benign cysts will be observed over the following year in 3-4 monthly intervals in order to detect any change in appearance or increase in size, which would be suspicious of maligna

Sponsors

University College London Hospital NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women found to have an ovarian cyst / adnexal mass 2. Postmenopausal women known to have an ovarian cyst / adnexal mass and referred for an opinion 3. Women who do not have any significant pain or bloating not explained but other pathology. Postmenopausal women are defined as those who have had 1 year of spontaneous amenorrhoea above or at the age of 40 where no illness or medication may have caused the amenorrhoea or those above or at the age of 50 who have had a hysterectomy.

Exclusion criteria

Exclusion criteria: 1. Pre-menopausal women 2. Women with pain localised to the area of the cyst or the lower abdomen 3. Women below 40 or above 80 years of age 4. Written informed consent declined or patients unable to give consent 5. Women not medically fit for surgery 6. Women with simple unilateral unilocular cysts of less than 2cm

Design outcomes

Primary

MeasureTime frame
The number of surgical interventions in the two study groups

Secondary

MeasureTime frame
1. Number of staging laparotomies 2. Diagnostic accuracy of the two protocols 3. Number of blood tests to measure tumour markers 4. Number of surgical complications

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026