Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Nov 1;8(11):e024108.
doi: 10.1136/bmjopen-2018-024108.

Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study

Khadra Galaal  1 , Alberto Lopes  2 , Colin Pritchard  3 , Andrew Barton  4 , Jennifer Wingham  5 , Elsa M R Marques  6 , John Faulds  7 , Joanne Palmer  3 , Patricia Jane Vickery  8 , Catherine Ralph  9 , Nicole Ferreira  7 , Paul Ewings  4
Affiliations
Randomized Controlled Trial

Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study

Khadra Galaal et al. BMJ Open. .

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 and analysis: 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 1:1 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.

Keywords: cytoreductive surgery; donor blood transfusion; feasibility trial; intraoperative cell salvage; ovarian cancer; quality of life.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Summary of trial design. ICS, intraoperative cell salvage.
See this image and copyright information in PMC

References

    1. Cancer Research UK, 2014. Ovarian cancer incidence statistics. http://www.cancerresearchuk.org/cancer
    1. National Cancer Intelligence Network (NCIN). Overview of ovarian cancer in england: incidence, mortality and survival. trent cancer registry november 2012. 2012.
    1. Schwartz PE. Cytoreductive surgery in the management of ovarian cancer. Oncology 2008;22:1025–33. - PubMed
    1. Peiretti M, Zanagnolo V, Aletti GD, et al. Role of maximal primary cytoreductive surgery in patients with advanced epithelial ovarian and tubal cancer: Surgical and oncological outcomes. Single institution experience. Gynecol Oncol 2010;119:259–64. 10.1016/j.ygyno.2010.07.032 - DOI - PubMed
    1. Prescott LS, Aloia TA, Brown AJ, et al. Perioperative blood transfusion in gynecologic oncology surgery: analysis of the National Surgical Quality Improvement Program Database. Gynecol Oncol 2015;136:65–70. 10.1016/j.ygyno.2014.11.009 - DOI - PMC - PubMed

Publication types

Associated data