The operator effect on the ultrasound diagnosis of ovarian tumours: a prospective randomised study
| ISRCTN | ISRCTN02631195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02631195 |
| Protocol serial number | N0116148369 |
| Sponsor | Department of Health |
| Funders | Kings College Hospital NHS Trust R&D Consortium (UK), Own Account NHS R&D support funding (UK) |
- 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
Scientific
Department of Obstetrics and Gynaecology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The main endpoint measure will be the number of invasive operative tests performed in each arm of the study. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 165 |
| Key inclusion criteria | Women who attend the Rapid Access Clinic at Guy's hospital with a suspected pelvic mass. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 19/04/2004 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Obstetrics and Gynaecology
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
