title: Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study.
abstract: OBJECTIVE
  Inadequate bowel cleansing is a major burden for endoscopy units. The aim of this study was to compare two intensive bowel cleansing regimens in patients with previous colonoscopy with inadequate bowel preparation.
  
  
  METHODS
  Patients with inadequate cleansing at index colonoscopy were randomized to 4-L split-dose polyethylene-glycol (PEG) regimen vs. 2-L split-dose PEG plus ascorbic acid (PEG+Asc) regimen. All individuals underwent a 3-day low-residue diet and received 10 mg of bisacodyl, the day before colonoscopy. Cleansing was considered to be adequate if the Boston Bowel Preparation Scale scored ≥2 at each colonic segment. A non-inferiority analysis was performed to demonstrate that colonic cleansing with 2-L PEG+Asc was not inferior to 4-l PEG, considering a non-inferiority margin of 10%.
  
  
  RESULTS
  Adequate bowel cleansing was significantly higher in patients assigned to 4-L PEG regimen (n=127) vs. those randomized to 2-L PEG+Asc regimen (n=129) by intention-to-treat analysis (81.1 vs. 67.4%, odds ratio (OR) 2.07, 95% confidence interval (CI) (1.163-3.689)) and by per-protocol analysis (86.6 vs. 71.7%, OR: 2.55, 95% CI: (1.316-4.922)). The study was terminated for futility after the interim analysis, because the 95% CI of the difference of proportions was 3.13-24.27% in the intention-to-treat analysis and 3.33-26.47% in the per-protocol analysis, confirming the superiority of 4-L PEG preparation.
  
  
  CONCLUSIONS
  After 3-day low-residue diet and oral bisacodyl before colonoscopy, colon cleansing with 4-L split-dose PEG was superior to 2-L split-dose PEG+Asc in patients with previous inadequate cleansing. (EUDRACT: 2013-002506-31, NCT02073552).
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Antonio Z
authors.initials: AZ
authors.lastname: Gimeno-García
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Goretti
authors.initials: G
authors.lastname: Hernandez
authors.affiliation: Unidad de Ensayos Clínicos, Hospital Universitario de Canarias.
authors.forename: Ana
authors.initials: A
authors.lastname: Aldea
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Nicolás-Pérez
authors.affiliation: Unidad de Investigación, Hospital Universitario de Canarias.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Jiménez
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Carrillo
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Vanesa
authors.initials: V
authors.lastname: Felipe
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Onofre
authors.initials: O
authors.lastname: Alarcón-Fernández
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Hernandez-Guerra
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Romero
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Alonso
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Yanira
authors.initials: Y
authors.lastname: Gonzalez
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Zaida
authors.initials: Z
authors.lastname: Adrian
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Moreno
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Ramos
authors.affiliation: Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Quintero
mesh_terms: D000236:Adenoma / Q000175:diagnosis*; D000368:Aged; D001205:Ascorbic Acid / Q000008:administration & dosage; D001726:Bisacodyl / Q000008:administration & dosage; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects; D002432:Cecum; D003111:Colonic Polyps / Q000175:diagnosis*; D003113:Colonoscopy / Q000379:methods*; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D004043:Dietary Fiber / Q000008:administration & dosage; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007441:Intubation, Gastrointestinal; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D014815:Vitamins / Q000008:administration & dosage
chemical_list: D002400:Cathartics; D004043:Dietary Fiber; D014815:Vitamins; D001726:Bisacodyl; D011092:Polyethylene Glycols; D001205:Ascorbic Acid