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An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial.

ABSTRACT: Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI). Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP. Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI-7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI-3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found. Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489). Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03830489.

SUBMITTER: Gimeno-Garcia AZ

PROVIDER: S-EPMC8019748 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial.

Gimeno-García Antonio Z AZ Hernández Goretti G Baute Dorta José Luis JL Reygosa Cristina C de la Barreda Raquel R Hernandez-Bustabad Alberto A Amaral Carla C Cedrés Yaiza Y Del Castillo Rocío R Nicolás-Pérez David D Jiménez Alejandro A Alarcon-Fernández Onofre O Hernandez-Guerra Manuel M Romero Rafael R Alonso Inmaculada I González Yanira Y Adrian Zaida Z Hernandez Domingo D Ramos Laura L Carrillo Marta M Felipe Vanessa V Hernández Anjara A Rodríguez-Jiménez Consuelo C Quintero Enrique E

Frontiers in medicine 20210322

<b>Objective:</b> We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI). <b>Methods:</b> This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to ...[more]

PMID: 33829030

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Project description:Abstract Aims Failed bowel preparation is common during colonoscopy, yet the optimal purgative regimen to use for the next attempt is unknown. The objective of this study was to compare the efficacy, tolerability, and safety of two regimens at supratherapeutic doses for use after failed bowel preparation. Methods A multi-centre phase III endoscopist blinded randomized controlled trial (NCT02976805) was conducted in patients who failed bowel preparation, using the US Multi-Society Task Force (USMSTF) definition of inability to exclude polyps >5 mm in size and requiring a shortened interval to next colonoscopy. Regimen A consisted of 15 mg of bisacodyl and 2 + 2 L of split dose polyethylene glycol electrolyte solution (PEG) and Regimen B consisted of 15 mg of bisacodyl and 4 + 2 L of split dose PEG. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥ 6 with all segment scores ≥ 2. Secondary outcomes were adequate bowel preparation using the USMSTF definition, median BBPS, adenoma detection (ADR), advanced adenoma detection (aADR), sessile serrated polyp detection (SSPDR), and cecal intubation (CIR). Adverse events were assessed at the time of the colonoscopy and 14 days later. Results Between February 2017 and December 2019, 250 subjects were screened at four academic centres in Canada, of which 195 were randomized: 96 to Regimen A and 99 to Regimen B. The mean (SD) age was 60.6 (11.4) years, 87 (45.1%) were female, and the median (IQR) total BBPS score at previous failed colonoscopy was 3 (1,4). Regimen B was not superior to Regimen A in achieving adequate bowel preparation using the BBPS definition (87.6% vs. 91.1%, p=0.45) or the USMSTF definition (85.4% vs 91.1%, p=0.24), nor was it superior with respect to the median BBPS score (7 vs 7, p=0.50), mean ADR (31.5% vs 37.8%, p=0.37), aADR (11.2% vs 18.9%, p=0.15), SSPDR (5.6% vs 8.9%, p=0.40) or CIR (92.1% vs 96.7%, p=0.19). Regimen A had a higher adherence rate (88.2% vs. 74.7%, p=0.02) and greater willingness to undergo the bowel preparation again (91.2% vs. 66.2%, p<0.001). The only serious adverse event occurred in a patient randomized to Regimen B who was admitted to hospital for vomiting after colonoscopy. Conclusions Split dose 4L PEG with 15mg of bisacodyl is highly efficacious, well tolerated, and can be used for patients who previously failed first line bowel preparations. The additional 2L of PEG in Regimen B did not improve bowel preparation and was not as well tolerated. Funding Agencies AMOSO Opportunities Grant, Pharmascence Inc.

Project description:ImportanceAdequate bowel preparation is essential for diagnostic, screening, and surveillance colonoscopy. Virtual reality (VR) has the characteristics of immersion, interaction, and imagination and has been widely used in medicine for training and teaching, indicating that it could be used in the education of outpatients for bowel preparation before colonoscopy.ObjectiveTo investigate whether using VR videos for patient education before colonoscopy could improve bowel preparation.Design, setting, and participantsA prospective, single-blinded, randomized clinical trial of 346 patients undergoing colonoscopy with local anesthesia in a tertiary care hospital was conducted between October 1, 2018, and November 1, 2020. Outpatients who had indications for colonoscopy and had not received one before were enrolled. Statistical analysis was performed from November 1 to December 31, 2020. All data were analyzed according to the intention-to-treat approach.ExposuresConventional bowel preparation education (oral instructions and written materials that had the same contents) or conventional education plus VR videos.Main outcomes and measuresThe primary outcome was the quality of bowel preparation measured by the Boston Bowel Preparation Scale score (range, 0-9, where 0 indicates extremely unsatisfactory bowel preparation and 9 indicates complete bowel preparation). Secondary outcomes included polyp and adenoma detection rates, compliance with complete bowel cleansing, preprocedure anxiety, overall satisfaction, and willingness to undergo a follow-up colonoscopy.ResultsA total of 346 outpatients were enrolled in the trial, with 173 patients randomly assigned to each group (control group: 87 women [50.3%]; mean [SD] age, 50.5 [12.5] years; VR video group: 84 women [48.6%]; mean [SD] age, 52.6 [11.4] years). Baseline characteristics, including demographic information, medical history, lifestyle, and the characteristics of stool, were comparable between the VR video group and the control group. The mean (SD) Boston Bowel Preparation Scale score was significantly higher in the VR video group than in the control group (7.61 [1.65] vs 7.04 [1.70]; P = .002). The detection rate of polyps (72 of 172 [41.9%] vs 46 of 172 [26.7%]; P = .003) and the detection rate of adenomas (56 of 172 [32.6%] vs 38 of 172 [22.1%]; P = .03) were also higher in the VR video group. Patients who received VR education had better compliance (119 [68.8%] vs 87 [50.3%]; P < .001) and higher mean (SD) overall satisfaction (8.68 [1.70] vs 8.16 [2.15]; P = .01) with bowel preparation.Conclusions and relevancePatients who received VR video education before colonoscopy had better bowel preparation, higher polyp and adenoma detection rates, and improved compliance and satisfaction.Trial registrationClinicalTrials.gov Identifier: NCT03667911.

Dataset Information

An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial.

Publications

An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial.

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