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Tech Coloproctol. 2016 Oct;20(10):683-93. doi: 10.1007/s10151-016-1514-7. Epub 2016 Aug 10.

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

Author information

1
Department of Surgery, Yeovil District Hospital, Higher Kingston, Yeovil, UK.
2
Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK.
3
Southwest Research Design Service, Taunton and Somerset NHS Trust, Taunton, UK.
4
University Hospitals Bristol, Upper Maudlin Street, Bristol, UK.
5
Department of Pathology, Yeovil District Hospital, Higher Kingston, Yeovil, UK.
6
Leeds Institute of Cancer and Pathology, School of Medicine, St James's University Hospital, University of Leeds, Leeds, UK.
7
Department of Research and Development, St Mary's Hospital, Imperial College, London, UK.
8
Department of Surgery, Yeovil District Hospital, Higher Kingston, Yeovil, UK. nader.francis@ydh.nhs.uk.
9
Faculty of Science, University of Bath, Wessex House 3.22, Bath, BA2 7AY, UK. nader.francis@ydh.nhs.uk.

Abstract

BACKGROUND:

The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery.

METHODS:

Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity.

RESULTS:

Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups.

CONCLUSIONS:

The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

KEYWORDS:

Chemoradiotherapy; Feasibility; Rectal cancer; Technical performance

PMID:
27510524
DOI:
10.1007/s10151-016-1514-7
[Indexed for MEDLINE]
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