A novel digital rectoscope for the triage of lower gastrointestinal symptoms in primary care: a prospective multicentre feasibility study

Abstract

BackgroundA prospective multicentre observational Phase I feasibility study of a novel digital rectoscope and telestration software for the triage of lower gastrointestinal (GI) symptoms.AimTo determine if digital rectoscopy is feasible, acceptable and clinically safe.Design & settingEvaluation of clinician case reports and patient questionnaires from patients recruited from five primary care centres.MethodAdults meeting two week wait (2WW) criteria for suspected lower GI cancer or suspected new diagnosis or flare-up of inflammatory bowel disease (IBD) were enrolled. Examinations were performed by primary care practitioners using the LumenEye® rectoscope. The CHiP platform allowed immediate remote review by secondary care. A prospective analysis was performed of patient and clinician experiences, diagnostic accuracy, and cost.Results114 patients were recruited (46 (40%) females: 68 (60%) males). No serious adverse events were reported. 82 (75%) patients reported that examination was more comfortable than expected, 104 (94%) felt intervention was most convenient if delivered in the community. Clinicians were confident of their assessment in 100 (87%) examinations. Forty-eight (42.1%) patients subsequently underwent colonoscopy, flexible sigmoidoscopy, or CT virtual colonoscopy. The overall sensitivity and specificity of LumenEye® in identifying rectal pathology was 90.0% and 88.9%. It was 100%/100% for cancer, and 83.3%/97.8% for polyps. Following LumenEye® examination, 19 (17%) patients were discharged, with projected savings of £11,305.ConclusionDigital rectoscopy in primary care is safe, acceptable, and can reduce referrals. A Phase III randomised controlled trial is indicated to define its utility in reducing the burden on hospital diagnostic services.

Diagnostic yield from symptomatic lower gastrointestinal endoscopy in the UK: A British Society of Gastroenterology analysis using data from the National Endoscopy Database

“…The most common reason for flexible sigmoidoscopy in patients was isolated rectal bleeding; where flexible sigmoidoscopy is often preferred to colonoscopy due to better tolerance, lower risk of complications, and the high proportion of left‐sided pathology 40,41 . However, this paradigm needs to be revisited with the introduction of FIT‐testing, 42 as perhaps a better algorithm might be to perform a full colonoscopy for those who are FIT‐positive, whereas FIT‐negative patients could be triaged to lower risk examinations such as rectoscopy, or no investigation, reducing pressure on endoscopy services 43 …”