| Source of record | UK Trials |
| ISRCTN | ISRCTN02631195 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0116148369 |
| Public title | The operator effect on the ultrasound diagnosis of ovarian tumours: a prospective randomised study |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Ovarian cancer |
| 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. |
| Design/methodology | Prospective randomised controlled trial |
| Research ethics review | Not provided at time of registration
|
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Women who attend the Rapid Access Clinic at Guy's hospital with a suspected pelvic mass. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 19/04/2004 |
| Anticipated end date | 01/07/2006 |
| Status of trial | Completed |
| Target number of participants | 165 |
| Interventions | 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. |
| Primary outcome measure(s) | The main endpoint measure will be the number of invasive operative tests performed in each arm of the study. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/18207461 |
| Sources of funding | 1. Kings College Hospital NHS Trust R&D Consortium (UK)
2. Own Account NHS R&D support funding (UK) |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr D Jurkovic |
| Contact details | Department of Obstetrics and Gynaecology
King's College Hospital
Denmark Hill
London
United Kingdom
SE5 9RS |
| Contact telephone | +44 (0)20 7346 3168 |
| Contact email | davor.jurkovic@kingsch.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN02631195 |
| Date last extracted from ISRCTN register | 17/04/2008 |
