title: Computed tomographic colonography versus colonoscopy for investigation of patients with symptoms suggestive of colorectal cancer (SIGGAR): a multicentre randomised trial.
abstract: BACKGROUND
  Colonoscopy is the gold-standard test for investigation of symptoms suggestive of colorectal cancer; computed tomographic colonography (CTC) is an alternative, less invasive test. However, additional investigation after CTC is needed to confirm suspected colonic lesions, and this is an important factor in establishing the feasibility of CTC as an alternative to colonoscopy. We aimed to compare rates of additional colonic investigation after CTC or colonoscopy for detection of colorectal cancer or large (≥10 mm) polyps in symptomatic patients in clinical practice.
  
  
  METHODS
  This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for colonoscopy. Patients were randomly assigned (2:1) to colonoscopy or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome-the rate of additional colonic investigation-by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621.
  
  
  RESULTS
  1610 patients were randomly assigned to receive either colonoscopy (n=1072) or CTC (n=538). 30 patients withdrew consent, leaving for analysis 1047 assigned to colonoscopy and 533 assigned to CTC. 160 (30.0%) patients in the CTC group had additional colonic investigation compared with 86 (8.2%) in the colonoscopy group (relative risk 3.65, 95% CI 2.87-4.65; p<0.0001). Almost half the referrals after CTC were for small (<10 mm) polyps or clinical uncertainty, with low predictive value for large polyps or cancer. Detection rates of colorectal cancer or large polyps in the trial cohort were 11% for both procedures. CTC missed 1 of 29 colorectal cancers and colonoscopy missed none (of 55). Serious adverse events were rare.
  
  
  CONCLUSIONS
  Guidelines are needed to reduce the referral rate after CTC. For most patients, however, CTC provides a similarly sensitive, less invasive alternative to colonoscopy.
  
  
  BACKGROUND
  NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.
authors: Cancer Screening and Prevention Research Group, Imperial College London, St Mary's Hospital, Norfolk Place, London W2 1PG, UK. w.atkin@imperial.ac.uk
authors: Wendy
authors: W
authors: Atkin
authors: Edward
authors: E
authors: Dadswell
authors: Kate
authors: K
authors: Wooldrage
authors: Ines
authors: I
authors: Kralj-Hans
authors: Christian
authors: C
authors: von Wagner
authors: Rob
authors: R
authors: Edwards
authors: Guiqing
authors: G
authors: Yao
authors: Clive
authors: C
authors: Kay
authors: David
authors: D
authors: Burling
authors: Omar
authors: O
authors: Faiz
authors: Julian
authors: J
authors: Teare
authors: Richard J
authors: RJ
authors: Lilford
authors: Dion
authors: D
authors: Morton
authors: Jane
authors: J
authors: Wardle
authors: Steve
authors: S
authors: Halligan
mesh_terms: D000368:Aged; D003111:Colonic Polyps / Q000150:complications / Q000000981:diagnostic imaging; D023881:Colonography, Computed Tomographic / Q000379:methods*; D003113:Colonoscopy / Q000379:methods*; D015179:Colorectal Neoplasms / Q000150:complications / Q000000981:diagnostic imaging*; D055088:Early Detection of Cancer / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012017:Referral and Consultation / Q000706:statistics & numerical data; D012307:Risk Factors