Specialty: Cancer, Primary sub-specialty: Gynae
Conditions
Interventions
Sixty participants will be randomised in a 1:1 ratio to intraoperative cell salvage (ICS, re-infusion of their own blood) or donor blood transfusion during surgery. Participants and outcome assessors
Sponsors
Royal Cornwall Hospitals NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. 18 years old or over 2. Suspected or confirmed ovarian cancer (newly diagnosed) requiring cytoreductive surgery, whether primary or interval (following chemotherapy) 3. CT scan evidence (with or without clinical evidence) compatible with FIGO stage III/IV ovarian cancer/ primary peritoneal cancer at presentation* 4. ECOG Performance Status 0-1 5. Willing to participate and able to give written informed consent *CT features of pelvic mass (or features suggestive of primary peritoneal cancer) and extrapelvic involvement including ascites, omental disease, peritoneal thickening, bowel surface and/or mesentery involvement, enlarged pelvic and para-aortic lymph nodes, evidence of disease on diaphragm
Exclusion criteria
Exclusion criteria: 1. Diagnosis of concurrent malignancy 2. Pregnant 3. Donor transfusion during the week prior to surgery 4. Haemoglobinopathies (e.g. sickle cell, thalassaemia) 5. Unwilling to accept donor blood (e.g. on religious grounds)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Recruitment rate is recorded as the number of eligible participants who consent to participate in the study by 12 months 2. Feasibility of randomisation immediately pre-operatively is recorded by the time interval between randomisation and beginning of surgery 3. Attrition rate is recorded as the number of participants who consent to participate that remain in the study until the end of follow up at three months 4. Completeness of proposed outcome measures will be recorded as the number of complete specific data fields within CRFs and patient questionnaire booklets received at end of follow up at three months, out of the expected total number of CRFs and booklets 5. Success of blinding of allocation for participants and outcome assessor will be recorded by the number of participants and assessors who are inadvertently made aware of their treatment allocation during the trial period 6. Success of data collection tools and methods to collect resource use data will be recorded as the proportion of completed resource use data fields available at end of follow-up 7. Acceptability of the intervention to participants will be assessed by qualitative interviews 8. Acceptability of study participation to participants will be assessed by qualitative interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactJane Vickery
Outcome results
None listed