Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Miss Natalie Nunes


Contact details

University College London Hospitals
Clinc 3
Elizabeth Garrett Anderson Building
235 Euston Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

Most asymptomatic ovarian cysts/adnexal masses detected on ultrasound scan are benign. In these women, an operation to remove the cyst is not necessary. By avoiding surgery women are not exposed to surgical and anaesthetic complication and their care is more cost-effective. Postmenopausal women are more likely to suffer from other medical problems such as diabetes and high blood pressure, which increase operative and anaesthetic risks.

We do not expect to find a significant difference in the sensitivities for the diagnosis of ovarian cancer between the two protocols. We do expect, however, that the specificity of the new protocol will be better, which should translate into lower intervention rates.

This study hopefully will show that use of the ‘Simple Rules’ and conservative management will reduce intervention rate without significantly increasing risk to the patients. This would increase patient safety and result in significant savings for the NHS.

Ethics approval

North London Research Ethics Committee, 30/09/2010 ref: 10/H0724/48

Study design

Interventional single centre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Asymptomatic ovarian cysts or adnexal tumours in postmenopausal women


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 malignancy. Any suspicion of malignant change, however, would trigger a surgical intervention.

Patients will be randomized by pulling sequential sealed envelopes. These envelopes have been prepared from a computer generated randomization list created by the statistician.

1. The Risk of Malignancy Index (RMI) and the Royal College of Obstetricians and Gynaecologists green top guideline number 34 (October 2003) on postmenopausal cysts
2. Simple ultrasound scan rules by the International Ovarian Tumour Analysis Group (IOTA)

In both arms of the study women will classified into three groups:
1. Presumed malignant cyst
2. Presumed benign cyst
3. Cysts of indeterminate nature

The management strategies will be identical in both arms:
1. Women with presumed malignancies will have surgery or management in a tertiary cancer centre
2. Women with presumed benign cysts will be managed expectantly
3. Women with indeterminate findings will be operated on in local cancer units.

Once the scan (+/- blood test) is done all assessments place patient into 1 of 3 categories. The categories are Benign, Indeterminate risk and Malignant. Those with benign tumours are offered 4 monthly scans for 1 year, those with indeterminate tumours are offered surgery in her consultant’s team and those with malignant tumours are referred to the tertiary oncology team.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The number of surgical interventions in the two study groups

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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.

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals
United Kingdom

Sponsor information


University College London Hospital NHS Foundation Trust

Sponsor details

c/o Mr Philip Diamond
235 Euston Road
United Kingdom
+44 (0)845 155 5000

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

University College London Hospitals NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2017 results in (added 22/01/2019)

Publication citations

Additional files

Editorial Notes

22/01/2019: Publication reference added 30/09/2016: No publications found, verifying study status with principal investigator