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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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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).
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Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach.
Anderson, JC, Kahi, CJ, Sullivan, A, MacPhail, M, Garcia, J, Rex, DK
Gastrointestinal endoscopy. 2019;(3):591-598
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BACKGROUND AND AIMS Although water exchange may improve adenoma detection compared with CO2, it is unclear whether water is a better medium to fill the lumen during withdrawal and visualize the mucosa. Total underwater colonoscopy (TUC) involves the use of water exchange with the air valve off during insertion followed by the inspection of the mucosa under water. Our goal was to compare miss rates for TUC with standard CO2 for polyps and adenomas using a tandem colonoscopy design. METHODS We randomized participants to undergo tandem colonoscopies using TUC or CO2 first. In TUC, water exchange was performed during insertion, and withdrawal was performed under water. For the CO2 colonoscopy, both insertion and withdrawal were performed with CO2. The main outcomes were miss rates for polyps and adenomas for the first examination calculated as the number of additional polyps/adenomas detected during the second examination divided by the total number of polyps/adenomas detected for both examinations. Inspection times were calculated by subtracting the time for polypectomy, and care was taken to keep the times equal for both examinations. RESULTS A total of 121 participants were randomized with 61 having CO2 first. The overall miss rate for polyps was higher for the TUC-first group (81/237; 34%) compared with the CO2-first cohort (57/264; 22%) (P = .002). In addition, the overall miss rate for all adenomas was higher for the TUC-first group (52/146; 36%) compared with the CO2 group (37/159; 23%) (P = .025). However, 1 of the 3 endoscopists had higher polyp/adenoma miss rates for CO2, but these were not statistically significant differences. The insertion time was longer for TUC than for CO2. After adjusting for times, participant characteristics, and bowel preparation, the miss rate for polyps was higher for TUC than for CO2. CONCLUSIONS We found that TUC had an overall higher polyp and adenoma miss rate than colonoscopy performed with CO2, and TUC took longer to perform. However, TUC may benefit some endoscopists, an issue that requires further study. (Clinical trial registration number: NCT03231917.).
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Comparative efficacy of combination of 1 L polyethylene glycol, castor oil and ascorbic acid versus 2 L polyethylene glycol plus castor oil versus 3 L polyethylene glycol for colon cleansing before colonoscopy: Study protocol of a randomized, double-blind, single-center study.
Tian, X, Chen, WQ, Liu, XL, Chen, H, Liu, BL, Pi, YP
Medicine. 2018;(17):e0481
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Colonoscopy has been regarded as an important method of early diagnosing and treating gastrointestinal lesions; however adequate bowel preparation is critical one of many factors needed for successful colonoscopy. Although several modified or novel regimes have been developed, desired quality of bowel preparation has not yet been generated. Scattered evidences revealed that castor oil may have potential of effectively cleansing colon. It is noted that, however, prospective trial of exploring the value of castor oil in preparing bowel before colonoscopy is lacking. The aims of this study are to test the hypotheses that low dose castor oil (30 mL) may enhance potential of polyethylene glycol (PEG) and combination of low castor oil and ascorbic acid may halve the volume of PEG.This is a randomized, double-blind (endoscopist and assessor), single center trial with three-arm design. We will randomly assign 282 adult patients (≥18 years but < 75 years), who are scheduled to undergo colonoscopy, to receive either 3 L PEG alone, 2 L PEG plus 30 mL castor oil or combination of 1 L PEG, 30 mL castor oil and 5 g ascorbic acid. The bowel preparation quality based on Boston Bowel Preparation Scale (BBPS) is the primary outcome. The secondary outcomes include the first defecation time, total number of defecation, time of cecal intubation, detection rate of polyp and adenoma, willing to repeat the same regime, tolerance to regime, and adverse events.The study protocol has been approved by the Clinical Research Ethics Committees of Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital & Chongqing Cancer Center (2017[107]). The results from this trial will be submitted for publication in peer-reviewed journals, and will be presented at national and international conferences.
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Implementation intentions and colorectal screening: a randomized trial in safety-net clinics.
Greiner, KA, Daley, CM, Epp, A, James, A, Yeh, HW, Geana, M, Born, W, Engelman, KK, Shellhorn, J, Hester, CM, et al
American journal of preventive medicine. 2014;(6):703-14
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CONTEXT Low-income and racial/ethnic minority populations experience disproportionate colorectal cancer (CRC) burden and poorer survival. Novel behavioral strategies are needed to improve screening rates in these groups. BACKGROUND The study aimed to test a theoretically based "implementation intentions" intervention for improving CRC screening among unscreened adults in urban safety-net clinics. DESIGN Randomized controlled trial. SETTING/PARTICIPANTS Adults (N=470) aged ≥50 years, due for CRC screening, from urban safety-net clinics were recruited. INTERVENTION The intervention (conducted in 2009-2011) was delivered via touchscreen computers that tailored informational messages to decisional stage and screening barriers. The computer then randomized participants to generic health information on diet and exercise (Comparison group) or "implementation intentions" questions and planning (Experimental group) specific to the CRC screening test chosen (fecal immunochemical test or colonoscopy). MAIN OUTCOME MEASURES The primary study outcome was completion of CRC screening at 26 weeks based on test reports (analysis conducted in 2012-2013). RESULTS The study population had a mean age of 57 years and was 42% non-Hispanic African American, 28% non-Hispanic white, and 27% Hispanic. Those receiving the implementation intentions-based intervention had higher odds (AOR=1.83, 95% CI=1.23, 2.73) of completing CRC screening than the Comparison group. Those with higher self-efficacy for screening (AOR=1.57, 95% CI=1.03, 2.39), history of asthma (AOR=2.20, 95% CI=1.26, 3.84), no history of diabetes (AOR=1.86, 95% CI=1.21, 2.86), and reporting they had never heard that "cutting on cancer" makes it spread (AOR=1.78, 95% CI=1.16, 2.72) were more likely to complete CRC screening. CONCLUSIONS The results of this study suggest that programs incorporating an implementation intentions approach can contribute to successful completion of CRC screening even among very low-income and diverse primary care populations. Future initiatives to reduce CRC incidence and mortality disparities may be able to employ implementation intentions in large-scale efforts to encourage screening and prevention behaviors.
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A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients.
Jung, YS, Seok, HS, Park, DI, Song, CS, Kim, SE, Lee, SH, Eun, CS, Han, DS, Kim, YS, Lee, CK
Gut and liver. 2013;(6):681-7
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BACKGROUND/AIMS: A dietary regimen consisting of a clear liquid diet (CLD) for at least 24 hours is recommended for colonoscopy preparation. However, this requirement results in problems in patient compliance with bowel preparation. The aim of this study was to evaluate the efficacy of a CLD compared with a regular diet (RD) for colonoscopy preparation using a polyethylene glycol (PEG) solution. METHODS This was a multicenter, randomized, investigator-blind prospective study. A total of 801 healthy outpatients undergoing afternoon colonoscopy were randomized to either a CLD or RD in addition to a 4 L PEG regimen. RESULTS The quality of bowel cleansing was not different between the CLD and RD groups in terms of the proportion with excellent or good preparation. In addition, no significant differences were observed between the two groups for polyp and adenoma detection rates and overall adverse events. Good compliance with bowel preparation was higher in the RD group than in the CLD group. CONCLUSIONS A CLD for a full day prior to colonoscopy should not be mandatory for PEG-based bowel preparation. Dietary education concerning the avoidance of high-fiber foods for 3 days before colonoscopy is sufficient, at least for healthy outpatients.
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A prospective study of bowel preparation for colonoscopy with polyethylene glycol-electrolyte solution versus sodium phosphate in Lynch syndrome: a randomized trial.
van Vugt van Pinxteren, MW, van Kouwen, MC, van Oijen, MG, van Achterberg, T, Nagengast, FM
Familial cancer. 2012;(3):337-41
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Lynch gene carriers undergo regular surveillance colonoscopies. Polyethylene glycol-electrolyte solution (PEG) is routinely prescribed for bowel cleansing, but often poorly tolerated by patients. Sodium phosphate (NaP) may be an alternative. Prospective and random comparison of bowel preparation with PEG and NaP on colon cleansing and patients' acceptance. Patients, who previously underwent a colonoscopy, were invited to participate and randomly assigned to either PEG or NaP. They were asked to fill in a questionnaire about preparation tolerability and future preferences. The endoscopist filled out a report about the quality of colon cleansing. 125 Patients were included in the study. Nine (7%) were excluded because of missing data. The remaining 116 patients (53 PEG and 63 NaP) were included in the analysis. Baseline characteristics did not differ between groups. Before colonoscopy 20 (38%) patients using PEG experienced the preparation almost intolerable, in contrast to 7(11%) of those using NaP (P = 0.001). Eleven patients in the PEG group and 48 in the NaP group would prefer NaP in the future. The colonoscopy was poorly tolerated in 17% of the individuals in both groups (P = 0.963). The endoscopist observed a more than 75% clean colon in 83% of patients on PEG and in 71% of patients on NaP (P = 0.076), however the coecum (P = 0.025) and ascending colon was cleaner after PEG. Lynch patients tolerated NaP better and preferred this formula for future bowel preparation. Colon cleansing was suboptimal with both treatments with a tendency towards a cleaner proximal colon with PEG.
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Efficacy and tolerability of split-dose PEG compared with split-dose aqueous sodium phosphate for outpatient colonoscopy: a randomized, controlled trial.
Seo, EH, Kim, TO, Kim, TG, Joo, HR, Park, MJ, Park, J, Park, SH, Yang, SY, Moon, YS
Digestive diseases and sciences. 2011;(10):2963-71
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BACKGROUND AND AIMS Adequate bowel cleansing is essential for a high-quality, effective, and safe colonoscopy. The aims of this study were to compare the efficacy and tolerability of split-dose polyethylene glycol with aqueous sodium phosphate for outpatients who underwent scheduled colonoscopy. METHODS In this prospective trial, 207 outpatients (aged between 18 and 65 years, with normal renal function, at low risk for renal damage) were randomized to receive split-dose preparation of PEG (2 L/2 L) (N = 103) or NaP (45 mL/45 mL, 12 h apart) (N = 104) without strict diet restriction the day before colonoscopy. The bowel cleansing efficacy of preparations was rated according to the Ottawa scale and the patient tolerability was assessed using a patient questionnaire. RESULTS There was no significant difference between the two groups for the mean total score using the Ottawa bowel preparation scale (P = 0.181). Significantly greater residual colonic fluid was observed in the split-dose PEG group (1.24 ± 0.49) than in the NaP group (1.04 ± 0.53) (P = 0.007). Patient compliance, preference, and acceptance of a two preparation regimen were similar with no significant differences (P = 0.095, P = 0.280 and P = 0.408, respectively). The overall incidence of adverse events was not significantly different between the two groups; however, the split-dose PEG group tended to have fewer adverse events (52/103 [50.5%], 66/104 [63.5%], P = 0.059) and had significantly less nausea and vomiting (P = 0.036). CONCLUSIONS Split-dose PEG, compared with split-dose NaP, is associated with more residual colonic fluid, but produces equivalent colon cleansing efficacy and results in less nausea and vomiting, which might improve patient tolerability (clinical trial registration number NCT01229800).