title: Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.
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.
authors: Department of Surgery, Yeovil District Hospital, Higher Kingston, Yeovil, UK.|Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK.
authors: J D
authors: JD
authors: Foster
authors: Southwest Research Design Service, Taunton and Somerset NHS Trust, Taunton, UK.
authors: P
authors: P
authors: Ewings
authors: University Hospitals Bristol, Upper Maudlin Street, Bristol, UK.
authors: S
authors: S
authors: Falk
authors: Department of Pathology, Yeovil District Hospital, Higher Kingston, Yeovil, UK.
authors: E J
authors: EJ
authors: Cooper
authors: University Hospitals Bristol, Upper Maudlin Street, Bristol, UK.
authors: H
authors: H
authors: Roach
authors: Leeds Institute of Cancer and Pathology, School of Medicine, St James's University Hospital, University of Leeds, Leeds, UK.
authors: N P
authors: NP
authors: West
authors: Department of Research and Development, St Mary's Hospital, Imperial College, London, UK.
authors: B A
authors: BA
authors: Williams-Yesson
authors: Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK.
authors: G B
authors: GB
authors: Hanna
authors: Department of Surgery, Yeovil District Hospital, Higher Kingston, Yeovil, UK. nader.francis@ydh.nhs.uk.|Faculty of Science, University of Bath, Wessex House 3.22, Bath, BA2 7AY, UK. nader.francis@ydh.nhs.uk.
authors: N K
authors: NK
authors: Francis
mesh_terms: D000368:Aged; D059248:Chemoradiotherapy / Q000379:methods*; D003082:Colectomy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D012004:Rectal Neoplasms / Q000628:therapy*; D061665:Time-to-Treatment; D016896:Treatment Outcome
keywords: Chemoradiotherapy; Feasibility; Rectal cancer; Technical performance