The operator effect on the ultrasound diagnosis of ovarian tumours: a prospective randomised study

ISRCTN ISRCTN02631195
DOI https://doi.org/10.1186/ISRCTN02631195
Secondary identifying numbers N0116148369
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
17/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr D Jurkovic
Scientific

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

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOvarian cancer
InterventionThis 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 typeOther
Primary outcome measureThe main endpoint measure will be the number of invasive operative tests performed in each arm of the study.
Secondary outcome measuresNot provided at time of registration
Overall study start date19/04/2004
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants165
Key inclusion criteriaWomen who attend the Rapid Access Clinic at Guy's hospital with a suspected pelvic mass.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment19/04/2004
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Obstetrics and Gynaecology
London
SE5 9RS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

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

No information available

Own Account NHS R&D support funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2008 Yes No