Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study.
BMJ Open
; 8(11): e024108, 2018 11 01.
Article
em En
| MEDLINE
| ID: mdl-30389760
ABSTRACT
INTRODUCTION:
Ovarian cancer is the leading cause of death from gynaecological cancer, with more than 7000 new cases registered in the UK in 2014. In patients suitable for surgery, the National Institute of Health and Care Excellence guidance for treatment recommends surgical resection of all macroscopic tumour, followed by chemotherapy. The surgical procedure can be extensive and associated with substantial blood loss which is conventionally replaced with a donor blood transfusion. While often necessary and lifesaving, the use of donor blood is associated with increased risks of complications and adverse surgical outcomes. Intraoperative cell salvage (ICS) is a blood conservation strategy in which red cells collected from blood lost during surgery are returned to the patient thus minimising the use of donor blood. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery. METHODS ANDANALYSIS:
Sixty adult women scheduled for primary or interval ovarian cancer surgery at participating UK National Health Service Trusts will be recruited and individually randomised in a 11 ratio to receive ICS reinfusion or donor blood (as required) during surgery. Participants will be followed up by telephone at 30 days postoperatively for adverse events monitoring and by postal questionnaire at 6 weeks and 3 monthly thereafter, to capture quality of life and resource use data. Qualitative interviews will capture participants' and clinicians' experiences of the study. ETHICS AND DISSEMINATION This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref 16/SW/0256). Results will be disseminated via peer-reviewed publications and will inform the design of a larger trial. TRIAL REGISTRATION NUMBER ISRCTN19517317.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Métodos Terapêuticos e Terapias MTCI:
Terapias_biologicas
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Hemoterapia
Assunto principal:
Neoplasias Ovarianas
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Transfusão de Sangue
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Ovariectomia
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Recuperação de Sangue Operatório
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Procedimentos Cirúrgicos de Citorredução
Tipo de estudo:
Clinical_trials
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Guideline
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Qualitative_research
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Reino Unido