Prospective randomized controlled trial evaluating cap-assisted colonoscopy vs standard colonoscopy.
ABSTRACT: AIM:To study the significance of cap-fitted colonoscopy in improving cecal intubation time and polyp detection rate. METHODS:This study was a prospective randomized controlled trial conducted from March 2008 to February 2009 in a tertiary referral hospital at Sydney. The primary end point was cecal intubation time and the secondary endpoint was polyp detection rate. Consecutive cases of total colonoscopy over a 1-year period were recruited. Randomization into either standard colonoscopy (SC) or cap-assisted colonoscopy (CAC) was performed after consent was obtained. For cases randomized to CAC, one of the three sizes of cap was used: D-201-15004 (with a diameter of 15.3 mm), D-201-14304 (14.6 mm) and D-201-12704 (13.0 mm). All of these caps were produced by Olympus Medical Systems, Japan. Independent predictors for faster cecal time and better polyp detection rate were also determined from this study. RESULTS:There were 200 cases in each group. There was no significant difference in terms of demographic characteristics between the two groups. CAC, when compared to the SC group, had no significant difference in terms of cecal intubation rate (96.0% vs 97.0%, P = 0.40) and time (9.94 +/- 7.05 min vs 10.34 +/- 6.82 min, P = 0.21), or polyp detection rate (32.8% vs 31.3%, P = 0.75). On the subgroup analysis, there was no significant difference in terms of cecal intubation time by trainees (88.1% vs 84.8%, P = 0.40), ileal intubation rate (82.5% vs 79.0%, P = 0.38) or total colonoscopy time (23.24 +/- 13.95 min vs 22.56 +/- 9.94 min, P = 0.88). On multivariate analysis, the independent determinants of faster cecal time were consultant-performed procedures (P < 0.001), male patients (P < 0.001), non-usage of hyoscine (P < 0.001) and better bowel preparation (P = 0.01). The determinants of better polyp detection rate were older age (P < 0.001), no history of previous abdominal surgery (P = 0.04), patients not having esophagogastroduodenoscopy in the same setting (P = 0.003), trainee-performed procedures (P = 0.01), usage of hyoscine (P = 0.01) and procedures performed for polyp follow-up (P = 0.01). The limitations of the study were that it was a single-center experience, no blinding was possible, and there were a large number of endoscopists. CONCLUSION:CAC did not significantly different from SC in term of cecal intubation time and polyp detection rate.
Project description:Measures shown to improve the adenoma detection during colonoscopy (excellent bowel preparation, cecal intubation, cap fitted colonoscope to examine behind folds, patient position change to optimize colon distention, trained endoscopy team focusing on detection of subtle flat lesions, and incorporation of optimum endoscopic examination with adequate withdrawal time) are applicable to clinical practice and, if incorporated are projected to facilitate comprehensive colonoscopy screening program for colon cancer prevention. To determine adenoma and serrated polyp detection rate under conditions designed to optimize quality parameters for comprehensive screening colonoscopy. Retrospective analysis of data obtained from a comprehensive colon cancer screening program designed to optimize quality parameters. Academic medical center. Three hundred and forty-three patients between the ages of 50 years and 75 years who underwent first screening colonoscopy between 2009 and 2011 among 535 consecutive patients undergoing colonoscopy. Comprehensive colonoscopy screening program was utilized to screen all patients. Cecal intubation was successful in 98.8% of patients. The Boston Bowel Preparation Scale for quality of colonoscopy was 8.97 (95% confidence interval [CI]; 8.94, 9.00). The rate of adenoma detection was 60% and serrated lesion (defined as serrated adenomas or hyperplastic polyps proximal to the splenic flexure) detection was 23%. The rate of precancerous lesion detection (adenomas and serrated lesions) was 66%. The mean number of adenomas per screening procedure was 1.4 (1.2, 1.6) and the mean number of precancerous lesions (adenomas or serrated lesions) per screening procedure was 1.6 (1.4, 1.8). Retrospective study and single endoscopist experience. A comprehensive colonoscopy screening program results in high-quality screening with high detection of adenomas, advanced adenomas, serrated adenomas, and multiple adenomas.
Project description:The value of a colonoscopy quality assurance (QA) register may be questioned if it brings no new information on which to act for quality improvement, e. g. if self-assessed quality of colonoscopy performance correlates perfectly with registered performance.In this explorative study, 39 (33 Norwegian and 6 Swedish) out of 99 new endoscopists joining the Norwegian QA register Gastronet from 2008 to 2013 responded to an invitation to fill in a questionnaire for self-assessment of cecal intubation rate, polyp detection rate for polyps ≥ 5 mm (PDR-5 mm), withdrawal time, total examination time, and rates for severely painful and pain-free colonoscopies before receiving their first-time feedback of actually registered results from Gastronet. A linear regression analysis was applied to explore the correlation between experience level and quality of estimation.We included 2654 colonoscopies in our study. Endoscopists underestimated their cecal intubation rate (estimated 88.8 %, registered 93.1 %, P < 0.001), total procedure time (estimated 31.7 minutes, registered 37.2 minutes, P = 0.014), withdrawal time (estimated 9.8 minutes, registered 14.4 minutes, P = 0.006) and the rate of pain-free procedures (estimated 18.3 %, registered 24.5 %, P = 0.001). Pre-study colonoscopy experience was not correlated with estimated quality for any of the indicators.Apart from overestimation of severely painful examinations, endoscopists most often underestimated their colonoscopy performance. Self-assessed quality of colonoscopy performance may not be a satisfactory substitute for systematic registration of quality and not sufficiently valid to be acted upon.
Project description:BACKGROUND AND STUDY AIMS: The adenoma detection rate (ADR) is one of the quality measures in screening colonoscopy and is crucial for reducing colorectal cancer morbidity and mortality. Up to 25 % of adenomas are missed during colonoscopy. Endocuff is an easy-to-use device that is attached like a cap to the distal tip of the colonoscope in order to optimize visualization behind the folds of the colon and increase the ADR. This is the first prospective study of Endocuff-assisted colonoscopy (EC) in a screening population with follow-up to determine the ADR and adverse events of EC. PATIENTS AND METHODS: We prospectively enrolled asymptomatic patients referred for screening colonoscopy during the 4-month study period. We documented the Boston Bowel Preparation Scale (BBPS) score, cecal intubation rate, polyp detection rate, ADR, number of advanced adenomas, and number of adverse events. Colonoscopies were performed by five board-certified gastroenterologists. During follow-up, the patients were called 4 to 12 weeks after EC. RESULTS: A total of 104 EC procedures were performed. Cecal intubation was achieved in 99 % of the patients, with a median intubation time of 6 minutes. The polyp detection rate and ADR in our study were 72 % and 47 %, respectively, and 13.5 % of the lesions were advanced adenomas. A significant number of adenomas were detected in the right side of the colon. Considering all the adenomas and hyperplastic polyps above the sigmoid, we recommended that nearly 60 % of our patients repeat an endoscopic follow-up according to the existing Swiss guidelines. We noted no perforations or other serious adverse events, even in the patients with extensive diverticulosis. CONCLUSIONS: EC is feasible with the most commonly available colonoscopes without severe adverse events. EC seems to be a safe and effective device for increasing the ADR, including small adenomas in the right side of the colon. Therefore, this technique may be recommended in the future to increase the ADR in a screening population.
Project description:Objective:A colonoscopy study in sedated patients with air insufflation showed that right-lateral starting position (RLP) improved abdominal discomfort and reduced cecal intubation time. The aim of this study was to determine if RLP vs left-lateral starting position (LLP) may produce similar results in unsedated patients examined with a modified-water immersion (m-WI) method. Methods:Consecutive patients for diagnostic colonoscopy meeting the inclusion criteria were randomized. Patients and colonoscopist were unblinded. The m-WI method entailed suction during insertion not only for fecal debris evacuation but also to facilitate passage through difficult or angulated colonic flexures. Water was infused as needed when any difficulty was encountered during insertion. A bowel visualization scale (BVS) (0=totally blurred visualization; 1=blurred lumen visualization; 2=small fecal debris with clear mucosa visualization; 3= clear visualization) was used to evaluate the interference of fecal debris with cecal intubation rate and time. Results:A total of 142 patients (72 in RLP and 70 in LLP) were enrolled. The respective pain score, visual analog scale, (VAS) and cecal intubation rate were not significantly different. The cecal intubation time was nearly significantly different (13.4±4.5 min vs 11.7±5.4 min; p=0.054) and was significantly different in the constipation subgroup (16.0±3.5 min vs 8.6±3.8 min; p=0.001). The cecal intubation time based on BVS showed significant difference between RLP and LLP in Scale 2 (13.9±4.6 min vs 10.3±4.2 min; p=0.003) and Scale 2 and 3 combined (13.2±4.3 min vs 10.6±4.8 min; p=0.01), respectively. Conclusion:RLP did not improve the pain score, and LLP showed better performance in unsedated m-WI colonoscopy patients (ClinicalTrial.gov, NCT03489824).
Project description:BACKGROUND:Colonic transendoscopic enteral tubing (TET) requires double cecal intubation, raising a common concern of how to save cecal intubation time and make the tube stable. We hypothesized that cap-assisted colonoscopy (CC) might reduce the second cecal intubation time and bring potential benefits during the TET procedure. AIM:To investigate if CC can decrease the second cecal intubation time compared with regular colonoscopy (RC). METHODS:This prospective multicenter, randomized controlled trial was performed at four centers. Subjects ? 7 years needing colonic TET were recruited from August 2018 to January 2020. All subjects were randomly assigned to two groups. The primary outcome was the second cecal intubation time. Secondary outcomes included success rate, insertion pain score, single clip fixation time, purpose and retention time of TET tube, length of TET tube inserted into the colon, and all procedure-related (serious) adverse events. RESULTS:A total of 331 subjects were randomized to the RC (n = 165) or CC (n = 166) group. The median time of the second cecal intubation was significantly shorter for CC than RC (2.2 min vs 2.8 min, P < 0.001). In patients with constipation, the median time of second cecal intubation in the CC group (n = 50) was shorter than that in the RC group (n = 43) (2.6 min vs 3.8 min, P = 0.004). However, no difference was observed in the CC (n = 42) and RC (n = 46) groups of ulcerative colitis patients (2.0 min vs 2.5 min, P = 0.152). The insertion pain score during the procedure in CC (n = 14) was lower than that in RC (n = 19) in unsedated colonoscopy (3.8 ± 1.7 vs 5.4 ± 1.9; P = 0.015). Multivariate analysis revealed that only CC (odds ratio [OR]: 2.250, 95% confidence interval [CI]: 1.161-4.360; P = 0.016) was an independent factor affecting the second cecal intubation time in difficult colonoscopy. CC did not affect the colonic TET tube's retention time and length of the tube inserted into the colon. Moreover, multivariate analysis found that only endoscopic clip number (OR: 2.201, 95%CI: 1.541-3.143; P < 0.001) was an independent factor affecting the retention time. Multiple regression analysis showed that height (OR: 1.144, 95%CI: 1.027-1.275; P = 0.014) was the only independent factor influencing the length of TET tube inserted into the colon in adults. CONCLUSION:CC for colonic TET procedure is a safe and less painful technique, which can reduce cecal intubation time.
Project description:To compare same-day whole-dose vs split-dose of 2-litre polyethylene glycol electrolyte lavage solution (PEG-ELS) plus bisacodyl for colon cleansing for morning colonoscopy.Consecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e., same-day whole-dose or split-dose of 2-litre PEG-ELS. Investigators and endoscopists were blinded to the allocation. All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used. In addition, patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation. Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale (BBPS). In addition, endoscopists gave an overall grading of the quality of bowel preparation. Cecal intubation time, withdrawal time, total colonoscopy time, adenoma detection rate and number of adenomas detected for each patient were recorded. Sample size was calculated using an online calculator for binary outcome non-inferiority trial. Analyses was based upon intent-to-treat. Significance was assumed at P-value < 0.05.Data for 295 patients were analysed. Mean age was 62.0 ± 14.4 years old and consisted of 50.2 % male. There were 143 and 152 patients in the split-dose and whole-dose group, respectively. Split-dose was as good as whole-dose for quality of bowel preparation. The total BBPS score was as good in the split-dose group compared to the whole-dose group [6 (6-8) vs 6 (6-7), P = 0.038]. There was no difference in cecal intubation rate, cecal intubation time, withdrawal time, total colonoscopy time and adenoma detection rate. Median number of adenoma detected was marginally higher in the split-dose group [2 (1-3) vs 1 (1-2), P = 0.010]. Patients in the whole-dose group had more nausea (37.5% vs 25.2%, P = 0.023) and vomiting (16.4% vs 8.4%, P = 0.037), and were less likely to complete the bowel preparation (94.1% vs 99.3%, P = 0.020). Patients in the split-dose group were less likely to refuse the same bowel preparation regime (6.3% vs 13.8%, P = 0.033) and less likely to want to try another bowel preparation regime (53.8% vs 78.9%, P < 0.001).Splitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients.
Project description:Objectives and study aim ?Colonoscopy prevents colorectal cancer by removing adenomatous polyps, but missed adenomas lead to interval cancers. Different devices have been used to increase adenoma detection rates (ADR). Two such devices of interest are the transparent cap (Olympus) and Endocuff (ARC Medical). Our study aimed to compare differences in ADR between Endocuff-assisted colonoscopy (EAC), cap-assisted colonoscopy (CAC) and standard colonoscopy (SC). Patients and methods ?A sample size of 126 subjects was calculated to determine an effect size of 30?%. Patients undergoing screening or surveillance colonoscopy between March 2016 and January 2017 were randomized to SC, CAC or EAC groups. Three experienced endoscopists performed all colonoscopies. Patient demographics, procedure indication, Boston Bowel Prep Score (BBPS), withdrawal time, polyp size, location, histopathology, were analyzed. Results ?There was no difference in ADR (52?%, 40?% and 54?%) in the SC, CAC and EAC groups respectively ( P ?=?0.4). Similar findings were also observed for proximal ADR (45?%, 35?%, and 50?%, P ?=?0.4) and SSA detection rate (16?%, 14?%, and 23?%, P ?=?0.5). EAC detected higher mean ADR per colonoscopy compared to CAC (1.70 vs 0.76, P ?=?0.01). However, there was no significant difference in mean ADR per positive colonoscopy (2.08, 1.63, and 2.59, P ?=?0.21). Conclusion ?In a randomized controlled trial comparing AC to CAC and SC, neither device conferred additional benefits in ADR among high detectors. When comparing each device, EAC may be better than CAC at detecting more total adenomas.
Project description:Background:Delivery of high-quality colonoscopy and adherence to evidence-based surveillance guidelines is essential to a high-quality screening program, especially in safety net systems with limited resources. We sought to assess colonoscopy quality and ensure appropriate surveillance in a network of safety net practices. Methods:We identified age-eligible patients ages 50-75 within a Federally Qualified Health Center (FQHC) clinic system with evidence of colonoscopy in preceding 10 years. We performed chart reviews to assess key aspects of colonoscopy quality: bowel preparation quality, evidence of cecal intubation, cecal withdrawal time, and the adenoma detection rate. We then utilized established guidelines to assess and revise surveillance colonoscopy intervals, determine whether appropriate surveillance had taken place, and schedule overdue patients as appropriate. Results:Of 26,394 age-eligible patients, a total of 3,970 patients had evidence of prior colonoscopy and 1,709 charts were selected and reviewed. Mean age was 57, 54% identified as women and 51% identified as Hispanic. Of 1709 colonoscopies reviewed, 77% had data on bowel preparation, and of those, 85% had adequate preparation quality. Cecal intubation was documented in 89% of procedures. Adequate cecal withdrawal time was documented in 59% of those with documented cecal intubation. Overall adenoma detection rate was 42%. Initial surveillance interval was clearly stated in 72% (n = 1238) of procedures. Of these, initial recommended intervals were too short in 24.5% (n = 304) and too long in 3.6% (n = 45). A total of 132 patients (10.7%) were overdue for appropriate surveillance and were referred for follow-up colonoscopy. Conclusions:Overall, the quality of screening colonoscopy was high, but reporting was incomplete. We found fair adherence to evidence-based surveillance guidelines, with significant opportunities to extend surveillance intervals and improve adherence to best practices.
Project description:OBJECTIVES:The aim of this study was to test the ability of a commercially available natural language processing (NLP) tool to accurately extract examination quality-related and large polyp information from colonoscopy reports with varying report formats. BACKGROUND:Colonoscopy quality reporting often requires manual data abstraction. NLP is another option for extracting information; however, limited data exist on its ability to accurately extract examination quality and polyp findings from unstructured text in colonoscopy reports with different reporting formats. STUDY DESIGN:NLP strategies were developed using 500 colonoscopy reports from Kaiser Permanente Northern California and then tested using 300 separate colonoscopy reports that underwent manual chart review. Using findings from manual review as the reference standard, we evaluated the NLP tool's sensitivity, specificity, positive predictive value (PPV), and accuracy for identifying colonoscopy examination indication, cecal intubation, bowel preparation adequacy, and polyps ?10?mm. RESULTS:The NLP tool was highly accurate in identifying examination quality-related variables from colonoscopy reports. Compared with manual review, sensitivity for screening indication was 100% (95% confidence interval: 95.3%-100%), PPV was 90.6% (82.3%-95.8%), and accuracy was 98.2% (97.0%-99.4%). For cecal intubation, sensitivity was 99.6% (98.0%-100%), PPV was 100% (98.5%-100%), and accuracy was 99.8% (99.5%-100%). For bowel preparation adequacy, sensitivity was 100% (98.5%-100%), PPV was 100% (98.5%-100%), and accuracy was 100% (100%-100%). For polyp(s) ?10?mm, sensitivity was 90.5% (69.6%-98.8%), PPV was 100% (82.4%-100%), and accuracy was 95.2% (88.8%-100%). CONCLUSION:NLP yielded a high degree of accuracy for identifying examination quality-related and large polyp information from diverse types of colonoscopy reports.
Project description:OBJECTIVE: Polyp detection rate (PDR) is an accepted measure of colonoscopy quality. Several factors may influence PDR including time of procedure and order of colonoscopy within a session. Our unit provides evening colonoscopy lists (6-9 pm). We examined whether colonoscopy performance declines in the evening. DESIGN: Data for all National Health Service (NHS) outpatient colonoscopies performed at Norfolk and Norwich University Hospital in 2011 were examined. Timing, demographics, indication and colonoscopy findings were recorded. Statistical analysis was performed using multivariate regression. RESULTS: Data from 2576 colonoscopies were included: 1163 (45.1%) in the morning, 1123 (43.6%) in the afternoon and 290 (11.3%) in the evening. Overall PDR was 40.80%. Males, increasing age and successful caecal intubation were all significantly associated with higher polyp detection. The indications 'faecal occult blood screening' (p<0.001) and 'polyp surveillance' (p<0.001) were strongly positively associated and 'anaemia' (p=0.01) was negatively associated with PDR. Following adjustment for covariates, there was no significant difference in PDR between sessions. With the morning as the reference value, the odds ratio for polyp detection in the afternoon and evening were 0.93 (95% CI = 0.72-1.18) and 1.15 (95%CI = 0.82-1.61) respectively. PDR was not affected by rank of colonoscopy within a list, sedation dose or trainee-involvement. CONCLUSIONS: Time of day did not affect polyp detection rate in clinical practice. Evening colonoscopy had equivalent efficacy and is an effective tool in meeting increasing demands for endoscopy. Standardisation was shown to have a considerable effect as demographics, indication and endoscopist varied substantially between sessions. Evening sessions were popular with a younger population.