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Estimation of Absolute Risk of Colorectal Cancer Based on Healthy Lifestyle, Genetic Risk, and Colonoscopy Status in a Population-Based Study.
Carr, PR, Weigl, K, Edelmann, D, Jansen, L, Chang-Claude, J, Brenner, H, Hoffmeister, M
Gastroenterology. 2020;(1):129-138.e9
Abstract
BACKGROUND & AIMS Estimates of absolute risk of colorectal cancer (CRC) are needed to facilitate communication and better inform the public about the potentials and limits of cancer prevention. METHODS Using data from a large population-based case-control study in Germany (Darmkrebs: Chancen der Verhütung durch Screening [DACHS] study, which began in 2003) and population registry data, we calculated 30-year absolute risk estimates for development of CRC based on a healthy lifestyle score (derived from 5 modifiable lifestyle factors: smoking, alcohol consumption, diet, physical activity, and body fatness), a polygenic risk score (based on 90 single-nucleotide polymorphisms), and colonoscopy history. RESULTS We analyzed data from 4220 patients with CRC and 3338 individuals without CRC. Adherence to a healthy lifestyle and colonoscopy in the preceding 10 years were associated with a reduced relative risk of CRC in men and women. We observed a higher CRC risk in participants with high or intermediate genetic risk scores. For 50-year-old men and women without a colonoscopy, the absolute risk of CRC varied according to the polygenic risk score and the healthy lifestyle score (men, 3.5%-13.4%; women, 2.5%-10.6%). For 50-year-old men and women with a colonoscopy, the absolute risk of developing CRC was much lower but still varied according to the polygenic risk score and the healthy lifestyle score (men, 1.2%-4.8%; women, 0.9%-4.2%). Among all risk factor profiles, the 30-year absolute risk estimates consistently decreased with adherence to a healthy lifestyle. CONCLUSIONS In a population-based study, we found that a colonoscopy can drastically reduce the absolute risk of CRC and that the genetically predetermined risk of CRC can be further reduced by adherence to a healthy lifestyle. Our results show the magnitude of CRC prevention possible through colonoscopy and lifestyle at a predefined genetic risk. This observational study has been registered in the German Clinical Trials Register (DRKS00011793), which is a primary registry in the World Health Organization Registry Network.
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The anti-spasmodic effect of peppermint oil during colonoscopy: a systematic review and meta-analysis.
Aziz, M, Sharma, S, Ghazaleh, S, Fatima, R, Acharya, A, Ghanim, M, Sheikh, T, Lee-Smith, W, Hamdani, SU, Nawras, A
Minerva gastroenterologica e dietologica. 2020;(2):164-171
Abstract
INTRODUCTION Multiple pharmacological agents have been studied in literature with antispasmodic effect during colonoscopy. Peppermint oil, with its relaxing effect on colon has demonstrated varying results. We therefore conducted a systematic review and meta-analysis of the available literature to evaluate its role during colonoscopy. EVIDENCE ACQUISITION Literature search of the following databases was undertaken: PubMed\Medline, Embase, Cochrane, Web of Science, and CINAHL. Outcomes that were evaluated included incidence of any spasticity, severe spasticity, and peristalsis during examination. Adenoma detection rate (ADR) was evaluated as a quality outcome metric. Risk ratios (RR), risk difference (RD) and mean difference (MD) were calculated using the DerSimonian-Laird method and random effects where applicable. EVIDENCE SYNTHESIS Overall, six studies (with one abstract) were included in this review. Peppermint oil resulted in overall lower incidence for spasticity (RD: -0.39, P=0.02), severe spasticity (RD: -0.15, P=0.04), and peristalsis (-0.27, P≤0.001) during colonoscopy examination. An improved ADR (RR: 1.31, P=0.01) was also noted, however only two studies evaluated this effect. CONCLUSIONS Peppermint oil resulted in relaxation of colon during colonoscopy with decrease incidence of spasticity, severe spasticity, peristalsis and improved ADR. These results are encouraging however results are limited due to significant heterogeneity found in the outcomes. Larger studies with standardized dosing are needed to evaluate this effect. Furthermore, studies evaluating additional colonoscopy outcomes such as polyp detection rate, advanced adenoma detection rate, and serrated adenoma detection rate are needed.
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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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Effectiveness and safety of NER1006 versus standard bowel preparations: A meta-analysis of randomized phase-3 clinical trials.
Maida, M, Macaluso, FS, Sferrazza, S, Ventimiglia, M, Sinagra, E
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2020;(8):833-839
Abstract
BACKGROUND A 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed. AIMS We conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations. METHODS PubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations. RESULTS Three RCTs (1879 participants) met the inclusion criteria and were included. The analysis showed a higher cleansing success for NER1006 compared standard preparations (OR=1.28; 95% CI 1.00-1.62; p = 0.047, I2=0%) as well as a greater high-quality cleansing of the right colon (OR=2.13; 95% CI 1.16-3.94; p = 0.015, I2=76.0%) when assessed by the Harefield Cleansing Scale (HCS). The pooled estimate of the NER1006 effect on ADR showed a higher, although not significant, ADR of the right colon (OR=1.19; 95% CI 0.73-1.92; p = 0.485, I2=53%). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of TEAEs (OR=2.31; 95% CI 1.82-2.94; p<0.001, I2=0%). CONCLUSIONS When compared to traditional preparations, NER1006 showed a better overall cleansing of the colon as well as a greater high-quality cleansing of the right colon, with comparable ADR. A higher incidence of mild to moderate TEAEs was observed for NER1006, in the absence of serious adverse events.
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Underwater versus conventional endoscopic resection of nondiminutive nonpedunculated colorectal lesions: a prospective randomized controlled trial (with video).
Yen, AW, Leung, JW, Wilson, MD, Leung, FW
Gastrointestinal endoscopy. 2020;(3):643-654.e2
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BACKGROUND AND AIMS Incomplete resection of colorectal neoplasia decreases the efficacy of colonoscopy. Conventional resection (CR) of polyps, performed in a gas-distended colon, is the current standard, but incomplete resection rates of approximately 2% to 30% for nondiminutive (>5 mm), nonpedunculated lesions are reported. Underwater resection (UR) is a novel technique. The aim of this study was to determine the incomplete resection rates of colorectal lesions removed by UR versus CR. METHODS In a randomized controlled trial, patients with small (6-9 mm) and large (≥10 mm) nonpedunculated lesions were assigned to CR (gas-distended lumen) or UR (water-filled, gas-excluded lumen). Small lesions in both arms were removed with a dedicated cold snare. For CR, large lesions were removed with a hot snare after submucosal injection. For UR, large lesions were removed with a hot snare without submucosal injection. Four-quadrant biopsy samples around the resection sites were used to evaluate for incomplete resection. RESULTS Four hundred sixty-two eligible polyps (248 UR vs 214 CR) from 255 patients were removed. Incomplete resection rates for UR and CR were low and did not differ (2% vs 1.9%, P = .91). UR was performed significantly faster for lesions ≥10 mm in size (10-19 mm, 2.9 minutes vs 5.6 minutes, P < .0001); ≥20 mm, 7.3 minutes vs 9.5 minutes, P = .015). CONCLUSIONS Low incomplete resection rates are achievable with UR and CR. UR is effective and safe with the advantage of faster resection and potential cost savings for removal of larger (≥10 mm) lesions by avoiding submucosal injection. As an added approach, UR has potential to improve the cost-effectiveness of colonoscopy by increasing efficiency and reducing cost while maintaining quality. (Clinical trial registration number: NCT02889679.).
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Colonic Decompression Reduces Proximal Acute Colonic Pseudo-obstruction and Related Symptoms.
Mankaney, GN, Sarvepalli, S, Arora, Z, Kamal, A, Lopez, R, Vargo, JJ, Burke, CA
Diseases of the colon and rectum. 2020;(1):60-67
Abstract
BACKGROUND Colonoscopic decompression is performed in inpatients for management of acute colonic pseudo-obstruction. Evidence for its efficacy is limited to small descriptive studies published before the use of neostigmine for acute colonic pseudo-obstruction. Furthermore, therapeutic end points were not defined. OBJECTIVE The aim was to compare the effectiveness of colonic decompression with standard medical therapy (supportive and pharmacologic therapy) to standard medical therapy alone. DESIGN This is a retrospective, propensity-matched study. SETTING The study was conducted at a tertiary care center. PATIENTS Inpatients with first diagnosis of acute colonic pseudo-obstruction between 2000 and 2016 were selected. INTERVENTIONS The intervention group received colonic decompression as well as supportive and/or pharmacologic therapy. The control group did not receive colonic decompression. MAIN OUTCOME MEASURES The primary outcome was the resolution of overall colonic dilation on imaging 48 hours following colonic decompression or the initiation of standard medical therapy alone. Secondary outcomes included symptom improvement, colonic segment diameter percentage change, perforation, 30-day readmission, and all-cause mortality. RESULTS The standard medical therapy and colonic decompression groups included 61 and 83 patients. Of the patients who underwent colonic decompression, 47.7% had complete resolution of acute colonic pseudo-obstruction versus 19.9% of patients who underwent standard medical therapy (p < 0.001). There were no significant differences in mid or distal colon diameter reduction between groups. The 30-day readmission rate was 15.7% in the colonic decompression group versus 26.2% in the standard medical therapy group. No immediate adverse events were noted in either group. Thirty-day all-cause mortality was 8.4% for the colonic decompression group and 14.8% in the standard medical therapy group. LIMITATIONS The study was a retrospective review on a highly comorbid population. CONCLUSIONS Colonic decompression is effective compared to standard medical therapy alone for proximal colonic dilation or symptoms associated with acute colonic pseudo-obstruction. On segmental analysis, colonic decompression does not provide any additional benefit over standard medical therapy in improving transverse or distal colonic dilation. See Video Abstract at http://links.lww.com/DCR/B32. LA DESCOMPRESIÓN COLÓNICA REDUCE LA PSEUDOOBSTRUCCIÓN COLÓNICA AGUDA PROXIMAL Y LOS SÍNTOMAS RELACIONADOS.: La descompresión colonica se realiza en pacientes hospitalizados para el tratamiento de la pseudoobstrucción colónica aguda. La evidencia de su eficacia se limita a pequeños estudios descriptivos antes del uso de neostigmina para la pseudoobstrucción colónica aguda. Además, los puntos finales terapéuticos no se definieron.El objetivo fue comparar la efectividad de la descompresión colónica mas el tratamiento médico estándar (tratamiento de apoyo y farmacológico) contra el tratamiento médico estándar solamente.Este es un estudio retrospectivo de propensión coincidente.El estudio se realizó en un centro de atención de tercer nivel.Pacientes hospitalizados con diagnóstico de pseudoobstrucción colónica aguda entre 2000 y 2016.El grupo de intervención recibió descompresión colónica, así como tratamiento de apoyo o farmacológica. El grupo control no recibió descompresión colónica.La medida de resultado primaria fue la resolución de la dilatación colónica general en la imagen 48 horas después de la descompresión colónica o el inicio del tratamiento médico estándar solo. Los resultados secundarios incluyeron mejoría de los síntomas, cambio porcentual en el diámetro del segmento colónico, perforación, reingreso a los 30 días y mortalidad por cualquier causa.La terapia médica estándar y los grupos de descompresión colónica incluyeron 61 y 83 pacientes, respectivamente. El 47,7% de los pacientes con descompresión colónica tuvieron una resolución completa de la pseudoobstrucción colónica aguda frente al 19,9% de los pacientes con terapia médica estándar (p < 0,001). No hubo diferencias significativas en la reducción del diámetro del colon medio o distal entre los grupos. La tasa de reingreso a los 30 días fue del 15,7% en el grupo de descompresión colónica frente al 26,2% en el grupo de tratamiento médico estándar. No se observaron eventos adversos inmediatos en ninguno de los dos grupos. La mortalidad por cualquier causa a los 30 días fue del 8.4% para la descompresión del colon y del 14.8% en los grupos de terapia médica estándar.El estudio fue una revisión retrospectiva en una población altamente comórbida.La descompresión colónica es efectiva en comparación con el tratamiento médico estándar solo para la dilatación del colon proximal o los síntomas asociados con la pseudoobstrucción colónica aguda. En el análisis segmentario, la descompresión colónica no proporciona ningún beneficio adicional sobre el tratamiento médica estándar para mejorar la dilatación colónica transversal o distal. Vea el resumen del video en http://links.lww.com/DCR/B32.
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Randomized Clinical Trial: A Normocaloric Low-Fiber Diet the Day Before Colonoscopy Is the Most Effective Approach to Bowel Preparation in Colorectal Cancer Screening Colonoscopy.
Alvarez-Gonzalez, MA, Pantaleon, MA, Flores-Le Roux, JA, Zaffalon, D, Amorós, J, Bessa, X, Seoane, A, Pedro-Botet, J, ,
Diseases of the colon and rectum. 2019;(4):491-497
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BACKGROUND Clinical guidelines recommend either a clear-liquid diet or a low-fiber diet for colonoscopy preparation. Participants in a screening program are usually motivated healthy individuals in which a good tolerability is important to improve adherence to potential surveillance colonoscopies. OBJECTIVE Our aim was to assess whether or not a normocaloric low-fiber diet followed the day before a screening colonoscopy compromises the efficacy of bowel cleansing and may improve the tolerability of bowel preparation. DESIGN This is a randomized, endoscopist-blinded, noninferiority clinical trial. SETTINGS The study was conducted at a tertiary care center. PATIENTS A total of 276 consecutive participants of the Barcelona colorectal cancer screening program were included. INTERVENTION Participants were randomly assigned to a clear-liquid diet or a normocaloric low-fiber diet the day before the colonoscopy. Both groups received 4 L of polyethylene glycol in a split-dose regimen. MAIN OUTCOME MEASURES Primary outcome was the adequate bowel preparation rate measured with the Boston bowel preparation scale. Secondary outcomes included tolerability, fluid-intake perception, hunger, side effects, and acceptability. RESULTS Participants in both groups were similar in baseline characteristics. Adequate bowel preparation was achieved in 89.1% vs 95.7% in clear-liquid diet and low-fiber diet groups, showing not only noninferiority, but also superiority (p = 0.04). Low-fiber diet participants reported less fluid-intake perception (p = 0.04) and less hunger (p = 0.006), with no differences in bloating or nausea. LIMITATIONS The single-center design of the study could limit the external validity of the results. The present findings may not be comparable to other clinical settings. CONCLUSION A normocaloric low-fiber diet the day before a screening colonoscopy achieved better results than a clear-liquid diet in terms of adequate colon preparation. Moreover, it also improved the perception of hunger and excessive fluid intake. Registered at clinicaltrials.gov: NCT02401802. See Video Abstract at http://links.lww.com/DCR/A829.
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A prospective RCT comparing combined chromoendoscopy with water exchange (CWE) vs water exchange (WE) vs air insufflation (AI) in adenoma detection in screening colonoscopy.
Leung, JW, Yen, AW, Jia, H, Opada, C, Melnik, A, Atkins, J, Feller, C, Wilson, MD, Leung, FW
United European gastroenterology journal. 2019;(4):477-487
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BACKGROUND A low adenoma detection rate (ADR) increases risks of interval cancers (ICs). Proximal colon flat polyps, e.g. serrated lesions (SLs), are difficult to find. Missed proximal colon flat lesions likely contribute to IC. AIMS We compared chromoendoscopy with water exchange (CWE), water exchange (WE) and air insufflation (AI) in detecting adenomas in screening colonoscopy. METHODS After split-dose preparation, 480 veterans were randomized to AI, WE and CWE. RESULTS Primary outcome of proximal ADR (55.6% vs 53.4% vs 52.2%, respectively) were similar in all groups. Adenoma per colonoscopy (APC) and adenoma per positive colonoscopy (APPC) were comparable. Detection rate of proximal colon SLs was significantly higher for CWE and WE than AI (26.3%, 23.6% and 11.3%, respectively, p = 0.002). Limitations: single operator; SLs only surrogate markers of but not IC. CONCLUSIONS When an endoscopist achieves high-quality AI examinations with overall ADR twice (61.6%) the recommended standard (30%), use of WE and CWE does not produce further improvement in proximal or overall ADR. Comparable APC and APPC confirm equivalent withdrawal inspection techniques. WE alone is sufficient to significantly improve detection of proximal SLs. The impact of increased detection of proximal SLs by WE on prevention of IC deserves to be studied. This study is registered at ClinicalTrial.gov (NCT#01607255).
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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).