Frontiers in Medicine (Mar 2021)

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

  • Antonio Z. Gimeno-García,
  • Antonio Z. Gimeno-García,
  • Goretti Hernández,
  • Goretti Hernández,
  • José Luis Baute Dorta,
  • José Luis Baute Dorta,
  • Cristina Reygosa,
  • Cristina Reygosa,
  • Raquel de la Barreda,
  • Raquel de la Barreda,
  • Alberto Hernandez-Bustabad,
  • Alberto Hernandez-Bustabad,
  • Carla Amaral,
  • Carla Amaral,
  • Yaiza Cedrés,
  • Yaiza Cedrés,
  • Rocío del Castillo,
  • Rocío del Castillo,
  • David Nicolás-Pérez,
  • David Nicolás-Pérez,
  • Alejandro Jiménez,
  • Onofre Alarcon-Fernández,
  • Onofre Alarcon-Fernández,
  • Manuel Hernandez-Guerra,
  • Manuel Hernandez-Guerra,
  • Rafael Romero,
  • Rafael Romero,
  • Inmaculada Alonso,
  • Inmaculada Alonso,
  • Yanira González,
  • Yanira González,
  • Zaida Adrian,
  • Zaida Adrian,
  • Domingo Hernandez,
  • Domingo Hernandez,
  • Laura Ramos,
  • Laura Ramos,
  • Marta Carrillo,
  • Marta Carrillo,
  • Vanessa Felipe,
  • Vanessa Felipe,
  • Anjara Hernández,
  • Anjara Hernández,
  • Consuelo Rodríguez-Jiménez,
  • Consuelo Rodríguez-Jiménez,
  • Enrique Quintero,
  • Enrique Quintero

DOI
https://doi.org/10.3389/fmed.2021.654847
Journal volume & issue
Vol. 8

Abstract

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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.

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