The WASh Trial: water-assisted sigmoidoscopy in the English Bowel Scope Screening Programme: study protocol for a randomized multicenter trial

Background and study aims:  The English National Bowel Scope Screening Programme (BSSP) invites 55-year-olds for a one-off, unsedated flexible sigmoidoscopy (FSIG). Data from BSSP participant-reported experience studies shows 1 in 3 participants report moderate or severe discomfort. Water-assisted colonoscopy (WAS) may improve participants' comfort. The primary objective of this study is to ascertain if post-procedural participant-assessed pain is reduced in WAS compared with carbon dioxide (CO 2 ) insufflation, in invitees undergoing FSIG in BSSP. Patients and methods  This is a multicenter, prospective, randomized, two-arm, single-blinded trial designed to evaluate the performance of WAS versus CO 2 insufflation in BSSP. Participants will be randomized to either CO 2 or WAS and will be asked to rate pain post-procedure. Key procedure-related data will be analyzed, including adenoma detection rates (ADR) and degree of sigmoid looping. A cost-effectiveness analysis of WAS versus CO 2 and a discrete choice experiment exploring preferences of participants for attributes of sigmoidoscopy will also be performed. Discussion  This is the first trial in the United Kingdom (UK) to investigate the effects of WAS in a screening setting. If the trial shows WAS either reduces pain or increases ADR, this may result in a practice change to implement WAS in screening and non-screening endoscopic practice directly impacting on 256,000 people a year who will undergo BSSP FSIG by 2020. Trial funding came from National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) supported by the NIHR Clinical Research Network. The trial is actively recruiting. ID: 35866 ISRCTN: 81466870

Colonoscopic cancer detection rate: A new performance measure - Is it FIT for purpose?

\ua9 Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.Introduction: Gastrointestinal symptoms correlate poorly with cancer diagnosis. A faecal immunochemical test (FIT) result of ≥10 μg has high sensitivity and negative predictive value for colorectal cancer (CRC) detection. An FIT-based diagnostic pathway may lead to more effective resource utilisation. We aimed to use National Endoscopy Database (NED) data to create a new colonoscopy performance measure, cancer detection rate (CDR) to assess the appropriate identification of target populations for colonoscopy; then to use CDR to assess the impact of implementing an FIT-based referral pathway locally. Methods: NED data were analysed to compare local diagnostic colonoscopic CDR in 2019 (prepathway revision) and 2021 (postpathway revision), benchmarked against overall national CDR for the same time frames. Results: 1, 123, 624 NED diagnostic colonoscopies were analysed. Locally, there was a significant increase in CDR between 2019 and 2021, from 3.01% (2.45%-3.47%) to 4.32% (3.69%-4.95%), p=0.003. The CDR increase was due to both a 10% increase in the number of CRCs detected and a 25% reduction in the number of diagnostic colonoscopies performed. Nationally, there was a smaller, but significant, increase in CDR from 2.02% (1.99%-2.07%) to 2.33% (2.29%-2.37%), p<0.001. The rate of increase in CDR% between 2019 and 2021 was significantly different locally compared with nationally. Conclusion: Our study indicates that the introduction of a robustly vetted FIT-based algorithm to determine whether diagnostic colonoscopy is required, is effective in increasing the colonoscopic CDR. Moreover, CDR appears to be a meaningful performance metric that can be automatically calculated through NED, enabling monitoring of the quality of referral and vetting pathways

Diagnostic yield of scope retroflexion in the right colon: A prospective cohort study

Background: Techniques have been implemented to improve colonoscopy adenoma detection rate (ADR) in the right colon. Aims & methods: We prospectively examined the additional diagnostic yield of right colon examination with colonoscope retroflexion in consecutive, symptomatic and screening-surveillance patients. Right colon was examined in forward-view first and thereafter, retroflexion was performed to re-inspect it. Results: Right colon examination in retroflexion was achieved in 620 (92%) patients. Increased inserted scope length to the cecum (OR: 0.48 [95%CI: 0.27-0.84]) and elderly status (OR: 0.53 [95%CI: 0.430-0.94]) predicted retrofexion failure. Forward-view colonoscopy detected 134 polyps and 112 adenomas in 105 and 85 patients, respectively. Scope retroflexion revealed 7 missed (6 adenomas - 2 advanced) polyps in 7 patients; indicating 4.96 (95%CI: 1.37-8.55)% and 5.1 (95%CI: 1.12-9.05)% per-polyp and per-adenoma miss rates, respectively. In ITT analysis, per-patient polyp and adenoma miss rates were 1.041% and 0.89%, respectively. Among screening-surveillance patients, retroflexion detected 3 missed adenomas (2 advanced) in 3 patients, resulting in changed surveillance schedule in 2 of them (5.12 per 1000 screening-surveillance patients). Early study termination was favored by low right colon ADR improvement and lacking substantial surveillance interval change. Conclusion: The additional diagnostic yield of scope retroflexion in the right colon is questionable. © 2015 Editrice Gastroenterologica Italiana S.r.l

WASh multicentre randomised controlled trial: water-assisted sigmoidoscopy in English NHS bowel scope screening

Objectives: The English Bowel Cancer Screening Programme invites 55 year olds for a sigmoidoscopy (Bowel Scope Screening (BSS)), aiming to resect premalignant polyps, thus reducing cancer incidence. A national patient survey indicated higher procedural pain than anticipated, potentially impacting on screening compliance and effectiveness. We aimed to assess whether water-assisted sigmoidoscopy (WAS), as opposed to standard CO2 technique, improved procedural pain and detection of adenomatous polyps. Design: The WASh (Water-Assisted Sigmoidoscopy) trial was a multicentre, single-blind, randomised control trial for people undergoing BSS. Participants were randomised to either receive WAS or CO2 from five sites across England. The primary outcome measure was patient-reported moderate/severe pain, as assessed by patients on a standard Likert scale post procedure prior to discharge. The key secondary outcome was adenoma detection rate (ADR). The costs of each technique were also measured. Results: 1123 participants (50% women, mean age 55) were randomised (561 WAS, 562 CO2 ). We found no difference in patient-reported moderate/severe pain between WAS and CO2 (14% in WAS, 15% in CO2; p=0.47). ADR was 15% in the CO2 arm and 11% in the WAS arm (p=0.03); however, it remained above the minimum national performance standard in both arms. There was no statistical difference in mean number of adenomas nor overall polyp detection rate. There was negligible cost difference between the two techniques. Conclusion: In the context of enema-prepared unsedated screening sigmoidoscopies performed by screening-accredited endoscopists, no difference in patient-reported pain was seen when using either a CO2 or WAS intubation technique. Trial registration number: ISRCTN8146687