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A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy.
Di Palma, JA, Bhandari, R, Cleveland, MV, Mishkin, DS, Tesoriero, J, Hall, S, McGowan, J
The American journal of gastroenterology. 2021;(2):319-328
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Abstract
INTRODUCTION A new tablet-based bowel prep for colonoscopy has been developed containing poorly absorbed sulfate salts which act to retain water within the intestinal lumen resulting in a copious diarrhea, thereby cleansing the bowel. This study evaluated the safety and efficacy of these oral sulfate tablets (OST) compared with a US FDA-approved bowel prep solution containing PEG3350, electrolytes, and ascorbate (polyethylene glycol and ascorbate [PEG-EA]). METHODS Five hundred fifteen adult patients (mean 57y) were enrolled in this single-blind, multicenter, noninferiority study. Subjects were assigned either PEG-EA or OST to be administered in a split-dose regimen starting the evening before colonoscopy. PEG-EA was taken according to its approved labeling (1 L of prep solution with 16 oz. of additional water) in the evening and again in the morning. OST patients took a total of 24 tablets. OST patients were administered 12 tablets in the evening, and the following morning. Patients consumed 16 ounces of water with each dose of 12 tablets and drank an additional 32 oz. of water with each dose. Colonoscopies were performed by blinded investigators. Cleansing efficacy was evaluated globally and segmentally using a 4-point scale (Excellent-no more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa. Good-feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa. Fair-enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa. Poor-large amounts of fecal residue and additional bowel preparation required). Scores of Good or Excellent were considered to be a success. Safety was assessed by spontaneously reported adverse events, solicited ratings of expected prep symptoms, and laboratory testing. RESULTS A high rate of cleansing success was seen with OST (92%), which was noninferior to PEG-EA (89%). Only a small proportion of subjects rated their expected gastrointestinal symptoms as severe (<5% for both preps). No clinically significant differences were seen between preps for chemistry and hematology parameters. No serious adverse experiences were reported with OST. DISCUSSION Sulfate tablets achieved a high level of cleansing in the study, comparable with US FDA-approved preps. OST was noninferior to PEG-EA in this study and achieved significantly more Excellent preps overall and in the proximal colon. The OST prep was well-tolerated, with a similar rate of spontaneously reported adverse experiences to PEG-EA and a low rate of severe expected gastrointestinal symptoms.
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A Prospective Multicenter Study Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
Han, S, Obuch, JC, Duloy, AM, Keswani, RN, Hall, M, Simon, V, Ezekwe, E, Menard-Katcher, P, Patel, SG, Aagard, E, et al
Academic medicine : journal of the Association of American Medical Colleges. 2020;(2):283-292
Abstract
PURPOSE The Next Accreditation System requires training programs to demonstrate competence among trainees. Within gastroenterology (GI), there are limited data describing learning curves and structured assessment of competence in esophagogastroduodenoscopy (EGD) and colonoscopy. In this study, the authors aimed to demonstrate the feasibility of a centralized feedback system to assess endoscopy learning curves among GI trainees in EGD and colonoscopy. METHOD During academic year 2016-2017, the authors performed a prospective multicenter cohort study, inviting participants from multiple GI training programs. Trainee technical and cognitive skills were assessed using a validated competence assessment tool. An integrated, comprehensive data collection and reporting system was created to apply cumulative sum analysis to generate learning curves that were shared with program directors and trainees on a quarterly basis. RESULTS Out of 183 fellowships invited, 129 trainees from 12 GI fellowships participated, with an overall trainee participation rate of 72.1% (93/129); the highest participation level was among first-year trainees (90.9%; 80/88), and the lowest was among third-year trainees (51.2%; 27/53). In all, 1,385 EGDs and 1,293 colonoscopies were assessed. On aggregate learning curve analysis, third-year trainees achieved competence in overall technical and cognitive skills, while first- and second-year trainees demonstrated the need for ongoing supervision and training in the majority of technical and cognitive skills. CONCLUSIONS This study demonstrated the feasibility of using a centralized feedback system for the evaluation and documentation of trainee performance in EGD and colonoscopy. Furthermore, third-year trainees achieved competence in both endoscopic procedures, validating the effectiveness of current training programs.
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Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study.
Maida, M, Sinagra, E, Morreale, GC, Sferrazza, S, Scalisi, G, Schillaci, D, Ventimiglia, M, Macaluso, FS, Vettori, G, Conoscenti, G, et al
World journal of gastroenterology. 2020;(16):1950-1961
Abstract
BACKGROUND The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution (Plenvu; Norgine, Harefield, United Kingdom) has been introduced on the evidence of three phase-3 randomized controlled trials, but it had never been tested in the real-life. AIM: To assess the effectiveness and tolerability of the 1 L preparation compared to 4 L and 2 L- PEG solutions in a real-life setting. METHODS All patients undergoing a screening or diagnostic colonoscopy after a 4, 2 or 1 L PEG preparation, were consecutively enrolled in 5 Italian centers from September 2018 to February 2019. The primary endpoints of the study were the assessment of bowel cleansing success and high-quality cleansing of the right colon. The secondary endpoints were the evaluation of tolerability, adherence and safety of the different bowel preparations. Bowel cleansing was assessed through the Boston Bowel Preparation Scale. Adherence was defined as consumption of at least 75% of each dose, while tolerability was evaluated through a semi-quantitative scale. Safety was systematically monitored through adverse events reporting. RESULTS Overall, 1289 met the inclusion criteria and were enrolled in the study. Of these, 490 patients performed a 4 L-PEG preparation (Selgesse®), 566 a 2 L-PEG cleansing (Moviprep® or Clensia®) and 233 a 1 L-PEG preparation (Plenvu®). Bowel cleansing by Boston Bowel Preparation Scale was 6.5 ± 1.5 overall and 6.3 ± 1.5, 6.2 ± 1.5, 7.3 ± 1.5 (P < 0.001) in the subgroups of 4 L, 2 L and 1 L-PEG preparation, respectively. Cleansing success was achieved in 72.4%, 74.1% and 90.1% (P < 0.001), while a high-quality cleansing of the right colon in 15.9%, 12.0% and 41.4% (P < 0.001) for 4 L, 2 L and 1 L-PEG preparation groups, respectively. The 1 L preparation was the most tolerated compared to the 2 and 4 L-PEG solutions in the absence of serious adverse events within any of the three groups. Multiple regression models confirmed 1 L PEG-ASC preparation as an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability. CONCLUSION This study supports the effectiveness and tolerability of 1 L PEG-ASC, also showing it is an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability.
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Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study.
Kwak, MS, Cha, JM, Yang, HJ, Park, DI, Kim, KO, Lee, J, Shin, JE, Joo, YE, Park, J, Byeon, JS, et al
Gut and liver. 2019;(2):176-182
Abstract
BACKGROUND/AIMS: The use of a low-volume bowel cleansing agent is associated with a greater willingness to undergo repeat colonoscopy. Oral sulfate solution (OSS) is a recently approved low-volume agent; however, its efficacy and safety in the elderly population remain unclear. We aimed to evaluate the efficacy, safety, and acceptability of the OSS preparation, in comparison to those of a standard polyethylene glycol (PEG; 4 L) preparation, in elderly patients. METHODS A multicenter, randomized, investigator-blinded study was conducted. Participants were randomized to receive OSS or 4-L PEG with a split-dose regimen. Bowel cleansing efficacy was assessed using the Boston Bowel Preparation Scale (BBPS). Acceptance, satisfaction, and preparation-related symptoms were recorded. Additionally, blood parameters were analyzed for electrolyte abnormalities and nephrotoxicity. RESULTS A total of 193 patients were analyzed. No group differences in overall bowel cleansing efficacy were observed, with "adequate"preparations achieved in 95.9% (93/97) and 94.8% (91/96) of patients in the OSS and 4L PEG groups, respectively (p=0.747). However, mean BBPS scores for the entire (p=0.010) and right colon (p=0.001) were significantly higher in the OSS group than in the 4-L PEG group. The severity of clinical adverse events and frequency of acute kidney injury were similarly low, and no clinically meaningful electrolyte changes were identified. Self-reported scores regarding amount (p<0.001) and feeling (p=0.007), as well as overall satisfaction (p=0.001) and willingness to repeat the preparation (92.8% vs 67.7%, p<0.001), were significantly better in the OSS group than in the 4-L PEG group. CONCLUSIONS In elderly individuals, OSS with a split-dose regimen has greater acceptability and comparable efficacy in bowel cleansing compared to 4-L PEG. (Clinical trials registration number: NCT03112967).
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Feasibility and outcomes of underwater endoscopic mucosal resection for ≥ 10 mm colorectal polyps.
Siau, K, Ishaq, S, Cadoni, S, Kuwai, T, Yusuf, A, Suzuki, N
Surgical endoscopy. 2018;(6):2656-2663
Abstract
BACKGROUND Underwater endoscopic mucosal resection (UEMR) is an emerging strategy for the management of colorectal polyps. We aimed to evaluate the efficacy and safety of UEMR for clinically significant (≥ 10 mm) colorectal polyps. METHODS We performed a prospective dual-centre study of polyps ≥ 10 mm undergoing UEMR between June 2014 and March 2017. Outcomes measured comprised: (1) completeness of resection at index UEMR, (2) intraprocedural and 30-day complications, (3) rates and predictors of submucosal lift, en bloc resection, polyp/adenoma recurrence and (4) pain score. Endoscopy records were correlated with histology. RESULTS 85 patients underwent UEMR of 97 polyps. Resection was endoscopically complete at index UEMR in 97.9%. The median pain score was 0 (no pain). Submucosal lift was required in 29.9% and correlated with polyp size ≥ 30 mm (p = 0.03) and clip placement (p = 0.004). En bloc resection was achieved in 45.4%, and inversely correlated with polyp size ≥ 20 mm (p < 0.001). 30-day complications (4.1%) were minor and consisted of intraprocedural bleeding (n = 2) and delayed bleeding (n = 2). 60.8% attended endoscopy post-UEMR after a median interval of 6 months, with 20.3% polyp and 13.6% adenoma recurrence. Polyp recurrence was associated with piecemeal resection (p = 0.04), recurrent polyp (p = 0.02), female sex (p = 0.01) and poor access (p = 0.005). Predictors for adenoma recurrence included female gender (p = 0.01) and difficult access (p < 0.001). Recurrence rates did not differ with polyp size, site, morphology, dysplasia status, submucosal injection, patient age, or study centre. CONCLUSIONS UEMR is an effective, safe and well tolerated option for significant colorectal polyps. Piecemeal resection, recurrent polyp, female gender, and difficult access are predictors of post-UEMR polyp recurrence.
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A prospective comparison of live and video-based assessments of colonoscopy performance.
Scaffidi, MA, Grover, SC, Carnahan, H, Yu, JJ, Yong, E, Nguyen, GC, Ling, SC, Khanna, N, Walsh, CM
Gastrointestinal endoscopy. 2018;(3):766-775
Abstract
BACKGROUND AND AIMS Colonoscopy performance is typically assessed by a supervisor in the clinical setting. There are limitations of this approach, however, because it allows for rater bias and increases supervisor workload demand during the procedure. Video-based assessment of recorded procedures has been proposed as a complementary means by which to assess colonoscopy performance. This study sought to investigate the reliability, validity, and feasibility of video-based assessments of competence in performing colonoscopy compared with live assessment. METHODS Novice (<50 previous colonoscopies), intermediate (50-500), and experienced (>1000) endoscopists from 5 hospitals participated. Two views of each colonoscopy were videotaped: an endoscopic (intraluminal) view and a recording of the endoscopist's hand movements. Recorded procedures were independently assessed by 2 blinded experts using the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT), a validated procedure-specific assessment tool comprising a global rating scale (GRS) and checklist (CL). Live ratings were conducted by a non-blinded expert endoscopist. Outcomes included agreement between live and blinded video-based ratings of clinical colonoscopies, intra-rater reliability, inter-rater reliability and discriminative validity of video-based assessments, and perceived ease of assessment. RESULTS Forty endoscopists participated (20 novices, 10 intermediates, and 10 experienced). There was good agreement between the live and video-based ratings (total, intra-class correlation [ICC] = 0.847; GRS, ICC = 0.868; CL, ICC = 0.749). Intra-rater reliability was excellent (total, ICC = 0.99; GRS, ICC = 0.99; CL, ICC = 0.98). Inter-rater reliability between the 2 blinded video-based raters was high (total, ICC = 0.91; GRS, ICC = 0.918; CL, ICC = 0.862). GiECAT total, GRS, and CL scores differed significantly among novice, intermediate, and experienced endoscopists (P < .001). Video-based assessments were perceived as "fairly easy," although live assessments were rated as significantly easier (P < .001). CONCLUSIONS Video-based assessments of colonoscopy procedures using the GiECAT have strong evidence of reliability and validity. In addition, assessments using videos were feasible, although live assessments were easier.
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Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation.
Hsieh, YH, Tseng, CW, Hu, CT, Koo, M, Leung, FW
Gastrointestinal endoscopy. 2017;(1):192-201
Abstract
BACKGROUND AND AIMS Adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma of any size, is a quality indicator. We tested the hypothesis that water exchange (WE) improves ADR but water immersion (WI) has no adverse effect on ADR compared with air insufflation (AI). METHODS A prospective study was conducted at the Dalin Tzu Chi Hospital in southern Taiwan and the Hualien Tzu Chi Hospital in eastern Taiwan on patients randomly assigned to WE, WI, or AI with stratification by the 3 study colonoscopists. The primary outcome was ADR. RESULTS From July 2013 to December 2015, 651 patients were recruited and randomized into 3 groups with a 1:1:1 ratio (217 patients per group). Overall, ADR met quality standards: WE 49.8% (95% CI, 43.2%-56.4%), AI 37.8% (95% CI, 31.6%-44.4%), and WI 40.6% (95% CI, 34.2%-47.2%). Compared with AI, WE significantly increased ADR (P = .016). There was no difference between WI and WE. ADRs of WI and AI were comparable. Compared with AI, WE confirmed a longer insertion time, higher cleanliness score, but similar adenoma per positive colonoscopy (APPC) and withdrawal time with polypectomy. Subgroup analysis found WE significantly increased ADR in propofol-sedated patients. Multivariate generalized linear mixed model analysis revealed that age ≥50 years, WE (vs AI), colonoscopy indication, no previous history of colonoscopy, and withdrawal time >8 minutes were significant predictors of increased ADR. CONCLUSIONS Confirmation of prior reports showing WE, but not WI, increased ADR further strengthened the validity of our observations. WE significantly increased ADR in propofol-sedated patients. The outcome differences justify assessment of the role of WE in colorectal cancer prevention. Similar APPC and withdrawal times suggest that adequate inspection was performed on colonoscope withdrawal in each of the study arms. (Clinical trial registration number: NCT01894191.).
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Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial.
Cadoni, S, Falt, P, Rondonotti, E, Radaelli, F, Fojtik, P, Gallittu, P, Liggi, M, Amato, A, Paggi, S, Smajstrla, V, et al
Endoscopy. 2017;(5):456-467
Abstract
Background and study aims Single-center studies, which were retrospective and/or involved unblinded colonoscopists, have suggested that water exchange, but not water immersion, compared with air insufflation significantly increases the adenoma detection rate (ADR), particularly in the proximal and right colon. Head-to-head comparison of the three techniques with ADR as primary outcome and blinded colonoscopists has not been reported to date. In a randomized controlled trial with blinded colonoscopists, we aimed to evaluate the impact of the three insertion techniques on ADR. Patients and methods A total of 1224 patients aged 50 - 70 years (672 males) and undergoing screening colonoscopy were randomized 1:1:1 to water exchange, water immersion, or air insufflation. Split-dose bowel preparation was adopted to optimize colon cleansing. After the cecum had been reached, a second colonoscopist who was blinded to the insertion technique performed the withdrawal. The primary outcome was overall ADR according to the three insertion techniques (water exchange, water immersion, and air insufflation). Secondary outcomes were other pertinent overall and right colon procedure-related measures. Results Baseline characteristics of the three groups were comparable. Compared with air insufflation, water exchange achieved a significantly higher overall ADR (49.3 %, 95 % confidence interval [CI] 44.3 % - 54.2 % vs. 40.4 % 95 %CI 35.6 % - 45.3 %; P = 0.03); water exchange showed comparable overall ADR vs. water immersion (43.4 %, 95 %CI 38.5 % - 48.3 %; P = 0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0 %, 95 %CI 20.0 % - 28.5 % vs. 16.9 %, 95 %CI 13.4 % - 20.9 %; P = 0.04) and a higher advanced ADR (6.1 %, 95 %CI 4.0 % - 9.0 % vs. 2.5 %, 95 %CI 1.2 % - 4.6 %; P = 0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange (P = 0.04). Water exchange achieved the highest cleanliness scores (overall and in the right colon). These variables were comparable between water immersion and air insufflation. Conclusions The design with blinded observers strengthens the validity of the observation that water exchange, but not water immersion, can achieve significantly higher adenoma detection than air insufflation. Based on this evidence, the use of water exchange should be encouraged.Trial registered at ClinicalTrials.gov (NCT02041507).
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Comparison of 4-L Polyethylene Glycol and 2-L Polyethylene Glycol Plus Ascorbic Acid in Patients with Inactive Ulcerative Colitis.
Kim, ES, Kim, KO, Jang, BI, Kim, EY, Lee, YJ, Lee, HS, Jeon, SW, Kim, HJ, Kim, SK, ,
Digestive diseases and sciences. 2017;(9):2489-2497
Abstract
BACKGROUND Although colonoscopy preparation may cause symptom flares in patients with ulcerative colitis (UC), little is known about the standard preparation regimen in this population. AIM: We aimed to compare 4L polyethylene glycol (4L-PEG) with 2L polyethylene glycol plus ascorbic acid (2L-PEG-Asc) in quiescent UC patients. METHODS Patients with inactive UC undergoing colonoscopy for surveillance or checkup of mucosal healing were prospectively enrolled at 5 tertiary hospitals. They were randomly assigned to 4L-PEG and 2L-PEG-Asc groups. The Boston Bowel Preparation Scale (BBPS) was used for the preparation quality. Symptoms were assessed using the Simple Clinical Colitis Activity Index (SCCAI) before colonoscopy, at 1 and 4 weeks after the procedure. RESULTS Overall, 109 patients were included in the study (4L-PEG group 53, 2L-PEG-Asc group 56, the mean age at diagnosis 42.25 years, male 77). The quality of preparation was comparable between the groups (BBPS ≥ 6, 96.2 vs. 92.9%, p = 0.679). Although 26 patients (23.8%) had increased SCCAI scores within 4 weeks after colonoscopy, resulting in a medication dose-up or add-on in 3 patients (2.7%), the rise in scores was not different between the groups. No serious adverse events during preparation were observed in either group. However, the 2L-PEG-Asc group was more likely to be willing to repeat the preparation with the same agent than the 4L-PEG group (82.1 vs. 64.2%, respectively, p = 0.034). CONCLUSION PEG-based regimens with different volumes are equally effective and safe in inactive UC patients. 2L-PEG-Asc is more acceptable in this population as indicated by the willingness for further usage.
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Adenoma detection with blue-water infusion colonoscopy: a randomized trial.
Lesne, A, Rouquette, O, Touzet, S, Petit-Laurent, F, Tourlonias, G, Pasquion, A, Rivory, J, Aguero Garcete, G, Scanzi, J, Chalumeau, S, et al
Endoscopy. 2017;(8):765-775
Abstract
UNLABELLED Background and aims Colonoscopy is currently the reference method to detect colorectal neoplasia, yet some adenomas remain undetected. The water infusion technique and dying with indigo carmine has shown interesting results for reducing this miss rate. The aim of this study was to compare the adenoma detection rate (adenoma and adenocarcinoma; ADR) and the mean number of adenomas per patient (MAP) for blue-water infusion colonoscopy (BWIC) versus standard colonoscopy. Methods We performed a multicenter, randomized controlled trial in eight units, including patients with a validated indication for colonoscopy (symptoms, familial or personal history, fecal occult blood test positive). Consenting patients were randomized 1:1 to BWIC or standard colonoscopy. All colonoscopies were performed by experienced colonoscopists. All colonoscopy quality indicators were prospectively recorded. Results Among the 1065 patients included, colonoscopies were performed completely for 983 patients (514 men; mean age 59.1). The ADR was not significantly different between the groups; 40.4 % in the BWIC group versus 37.5 % in the standard colonoscopy group (odds ratio [OR] 1.13; 95 % confidence interval [CI] 0.87 - 1.48; P = 0.35). MAP was significantly greater in the BWIC group (0.79) than in the standard colonoscopy group (0.64; P = 0.005). For advanced adenomas, the results were 50 (10.2 %) and 36 (7.3 %), respectively (P = 0.10). The cecal intubation rate was not different but the time to cecal intubation was significantly longer in BWIC group (9.9 versus 6.2 minutes; P < 0.001). Conclusion Despite the higher MAP with BWIC, the routine use of BWIC does not translate to a higher ADR. Whether increased detection ultimately results in a lower rate of interval carcinoma is not yet known. CLINICAL TRIALS REGISTRATION EudraCT 2012-A00548 - 35; NCT01937429.