| Source of record | UK Trials |
| ISRCTN | ISRCTN53863270 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | OV4 |
| Public title | A Randomised Study to Evaluate the Impact of Malignant Ascites on Well-Being and the Role of Breathing Exercises in Delaying the Reaccumulation of Recurrent Ascites |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Ovary |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Recurrent abdominal ascites that are a result of relapsed primary resistant cancer of the ovary
2. The ascites is asymptomatic and requires drainage
3. Patients must not be in sub-acute or complete bowel obstruction
4. Performance status <3
5. Life expectancy of at least 12 weeks
6. No longer receiving chemotherapy
7. Adequate haematological profile and biochemistry |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 01/05/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following the first ascitic tap patients are randomised to either:
1. Group A: No initial intervention, on recurrence requiring a second ascitic tap patients are taught breathing exercises and required to wear a form of abdominal binder. Treatment to continue until reaccumulation of ascites.
2. Group B: Patients are taught breathing exercises and required to wear a form of abdominal binder. On recurrence requiring a second ascitic tap patients are given daily diuretic therapy with frusemide and spironolactone until reaccumulation of ascites. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | North West Thames Research and Development
Smith and Nephew Foundation |
| Sponsor name | Smith and Nephew Foundation |
| Sponsor details | 15 Adam Street
London
United Kingdom
WC2N 6LA |
| Sponsor telephone | +44(0)20 7960 2276 |
| Sponsor website | http://www.snfoundation.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN53863270 |
| Date last extracted from ISRCTN register | 17/04/2008 |
