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

Background A prospective multicentre observational Phase I feasibility study of a novel digital rectoscope and telestration software for the triage of lower gastrointestinal (GI) symptoms.

Aim To determine if digital rectoscopy is feasible, acceptable and clinically safe.

Design & setting Evaluation of clinician case reports and patient questionnaires from patients recruited from five primary care centres.

Method Adults 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.

Results 114 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.

Conclusion Digital 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.