Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
17/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr D Jurkovic

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116148369

Study information

Scientific title

Acronym

Study hypothesis

To see whether an ultrasound scan performed in an expert centre could reduce the number of major surgical procedures performed in the management of ovarian pathology.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Ovarian cancer

Intervention

This will be a randomised prospective study, including all women who attend the Rapid Access Clinic at Guy's hospital with a suspected pelvic mass. An information leaflet about the study will be given to all those patients referred with a suspected pelvic mass. If an ultrasound is indicated and if these patients consent to participate in the study and they meet the inclusion criteria, they will be randomised by a sealed envelope system to having their scan at Guy's & St Thomas' (routine), or at King's (expert).

The result of the scan will be reviewed by the lead consultant who will decide on the method of management of these patients based on the result of the scan report and an agreed management protocol. Findings at the operation and that of the histological investigation will be recorded. Any additional tests performed to aid the diagnosis made on ultrasound will be recorded as well. We will compare the above data between the two groups i.e. those who had routine scanning and those who had expert scanning.

In women who undergo conservative management, a follow up scan and a blood test will be carried out at regular intervals and any changes in diagnosis or plan of management will be recorded. The cost of different methods of management will be assessed and compared: cost of bed occupancy, price of operation, theatre time, short term and long term recovery cost. All the data collected will be stored on Microsoft Excel spreadsheets, on a disk and will be password protected. Only those directly involved in the study will be able to access these data.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main endpoint measure will be the number of invasive operative tests performed in each arm of the study.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/04/2004

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women who attend the Rapid Access Clinic at Guy's hospital with a suspected pelvic mass.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

165

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

19/04/2004

Recruitment end date

01/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics and Gynaecology
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Kings College Hospital NHS Trust R&D Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own Account NHS R&D support funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18207461

Publication citations

  1. Results

    Yazbek J, Raju SK, Ben-Nagi J, Holland TK, Hillaby K, Jurkovic D, Effect of quality of gynaecological ultrasonography on management of patients with suspected ovarian cancer: a randomised controlled trial., Lancet Oncol., 2008, 9, 2, 124-131, doi: 10.1016/S1470-2045(08)70005-6.

Additional files

Editorial Notes