Intraoperative Cell Salvage vs Transfusion in Ovarian Cancer (TICTOC)
Research type
Research Study
Full title
A Randomised, Controlled feasibility trial of Intraoperative Cell Salvage vs Donor Blood Transfusion in Ovarian Cancer Surgery (TICTOC)
IRAS ID
188499
Contact name
Khadra Galaal
Contact email
Sponsor organisation
Royal Cornwall Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Ovarian cancer is diagnosed in about 6000 women in England each year. Surgery for ovarian cancer is often extensive and can result in substantial blood loss. Currently, donated blood is used to replace blood lost during surgery. An alternative method of replacing blood is to retrieve the blood lost, clean it and return it to the patient. This process is known as intraoperative cell salvage (ICS). Research has shown that patients who have had their own blood back do better than patients who have donor blood in non-cancer related surgery. We intend to conduct a large trial to assess the clinical and cost effectiveness of ICS for women undergoing surgery for ovarian cancer, compared with the usual practice of transfusing donor blood as required. A range of clinical and economic outcomes would need to be captured with a likely primary outcome of overall survival at five years. To assess whether a larger, fully powered trial can successfully be planned and delivered, we need to undertake a feasibility study. We will recruit 60 women ≥18 years with suspected or confirmed ovarian cancer requiring cytoreductive surgery in acute NHS Trusts in England. Participants will be assessed by a research nurse and randomly allocated to receive either ICS or donor blood if required during their operation. Participants will be telephoned 30 days post-operatively to monitor any adverse events and will complete postal quality of life questionnaires at specific time points. All participants will be followed up for 4.5 months after surgery and some for longer, as time allows. A researcher will interview some of the women about their personal experience in order to understand how well the research process worked. We also aim to interview the surgeons about their experience and views on ICS. The study will last for 24 months in total.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0256
Date of REC Opinion
14 Oct 2016
REC opinion
Further Information Favourable Opinion