Evaluating the clinical use and safety of LumenEye in an outpatient colorectal clinic: a single-centre retrospective cohort study

Background Digital rectoscopy may reduce demand on endoscopy units, particularly as part of a watch-and-wait (WAW) organ preservation strategy for rectal cancer. LumenEye is a digital rigid rectoscope offering high-resolution rectal visualisation, video streaming, and biopsy capability without sedation. This study aimed to evaluate the feasibility, safety, and clinical utility of LumenEye in a novel outpatient colorectal clinic primarily managing WAW patients. Methods A single centre, retrospective analysis of all patients who underwent a LumenEye examination in the WAW clinic between August 2023 and November 2024 was conducted. Demographic, procedural, referral, and outcome data were collected from electronic health records. Descriptive statistics summarised findings, and chi-square and logistic regression analyses identified factors associated with complications or early termination. Results A total of 327 procedures were performed; mean patient age was 67.6 years. Most procedures (54.1%, n = 177) were for WAW patients, with 52.6% of referrals originating from the colorectal multidisciplinary team. LumenEye was generally well tolerated: pain requiring analgesia occurred in 5.8% (n = 19), early termination in 2.1% (n = 7), and minor bleeding in 1.2% (n = 4). No perforations or infections occurred. One malignancy (0.3%) was missed but subsequently identified on flexible sigmoidoscopy. Multivariate analysis showed pain and bleeding were significant predictors of early termination (p < 0.001). Conclusion LumenEye is a safe and practical tool for outpatient rectal examination including rectal cancer patients undergoing WAW organ preservation strategy. Its minimal support requirements, and favourable safety profile suggest it may be a valuable alternative to traditional endoscopy, particularly in settings where access is limited.