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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18207461
Publication citations
-
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.