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
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 bet...
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Frontiers Media S.A.
2021-03-01
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Series: | Frontiers in Medicine |
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Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2021.654847/full |
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language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 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 Frontiers in Medicine bowel cleansing predictive score enhanced bowel preparation hard to prepare patients high volume bowel preparation low volume bowel preparation |
author_facet |
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 |
author_sort |
Antonio Z. Gimeno-García |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Medicine |
issn |
2296-858X |
publishDate |
2021-03-01 |
description |
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. |
topic |
bowel cleansing predictive score enhanced bowel preparation hard to prepare patients high volume bowel preparation low volume bowel preparation |
url |
https://www.frontiersin.org/articles/10.3389/fmed.2021.654847/full |
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doaj-b7004d09dc1f4d99969210c2994582712021-03-22T04:31:19ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2021-03-01810.3389/fmed.2021.654847654847An 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 TrialAntonio Z. Gimeno-García0Antonio Z. Gimeno-García1Goretti Hernández2Goretti Hernández3José Luis Baute Dorta4José Luis Baute Dorta5Cristina Reygosa6Cristina Reygosa7Raquel de la Barreda8Raquel de la Barreda9Alberto Hernandez-Bustabad10Alberto Hernandez-Bustabad11Carla Amaral12Carla Amaral13Yaiza Cedrés14Yaiza Cedrés15Rocío del Castillo16Rocío del Castillo17David Nicolás-Pérez18David Nicolás-Pérez19Alejandro Jiménez20Onofre Alarcon-Fernández21Onofre Alarcon-Fernández22Manuel Hernandez-Guerra23Manuel Hernandez-Guerra24Rafael Romero25Rafael Romero26Inmaculada Alonso27Inmaculada Alonso28Yanira González29Yanira González30Zaida Adrian31Zaida Adrian32Domingo Hernandez33Domingo Hernandez34Laura Ramos35Laura Ramos36Marta Carrillo37Marta Carrillo38Vanessa Felipe39Vanessa Felipe40Anjara Hernández41Anjara Hernández42Consuelo Rodríguez-Jiménez43Consuelo Rodríguez-Jiménez44Enrique Quintero45Enrique Quintero46Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainUnidad de Investigación. Hospital Universitario de Canarias, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainUICEC del Complejo Hospitalario Universitario de Canarias, Plataforma SCReN; Servicio de Farmacología Clínica, La Laguna, SpainDepartamento de Medicina Física y Farmacología, Facultad de Medicina, Universidad de La Laguna (ULL), La Laguna, SpainServicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, SpainCentro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, SpainObjective: 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.https://www.frontiersin.org/articles/10.3389/fmed.2021.654847/fullbowel cleansing predictive scoreenhanced bowel preparationhard to prepare patientshigh volume bowel preparationlow volume bowel preparation |