Impact of a Predictive Score of Bowel Preparation Quality in Clinical Practice

NCT03830489 | Completed Phase 4

• 1 other identifier: Score-guided colon cleansing
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center randomized controlled trial to compare the colon cleansing quality determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with high risk of poor colon cleansing defined as those patients with a score\> 1.225 following a predictive score previously published: one group will receive an intensified split-dose 4 L polyethylene glycol solution (PEG) plus bisacodyl and 3 days of fiber-free diet and the other group a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet. Patients with a score ≤ 1.225 will receive a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.

Conditions

Cleansing Quality of the Colon

Keywords

Cleansing quality score; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale

  This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points

  8 months

Secondary Outcomes (2)

• Proportion of polyps detected in each arm

  8 months

• Tolerance to bowel preparation

  8 months

Study Arms (2)

Large volume based preparation

EXPERIMENTAL

This strategy will consist of split dose 4 L polyethylene glycol plus 10 mg bisacodyl plus 3 days of fiber-free diet.

Drug: polyethylene glycol

Low volume based preparation

ACTIVE COMPARATOR

This strategy will consist of split dose 2 L polyethylene glycol plus Ascorbic acid plus 1 day of fiber-free diet

Drug: polyethylene glycol plus ascorbic acid

Interventions

polyethylene glycol DRUG

The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet

Large volume based preparation

polyethylene glycol plus ascorbic acid DRUG

The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet

Low volume based preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Outpatient colonoscopy
• Willing to participate (informed consent signed).

You may not qualify if:

• Intestinal perforation
• Poorly controlled arterial hypertension (HTAS\> 180 HTAD\> 100)
• Congestive heart failure
• NYHA III-IV
• Acute hepatic failure
• End-stage renal disease (creatinine \<15 ml / min dialysis or pre-dialysis)
• Pregnancy or breastfeeding
• Known hypersensitivity reaction to drug components
• Phenylketonuria or Glucose-6-phosphate dehydrogenase deficiency
• Dementia with difficulty in intake of Preparation
• Past history of poor bowel preparation colonic cleanliness
• Inability to follow the instructions

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Department of Gastroenterology

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

Location

Related Publications (6)

• Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.

  PMID: 28291237 RESULT

• Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.

  PMID: 28282690 RESULT

• Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.

  PMID: 25600879 RESULT

• Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.

  PMID: 22239959 RESULT

• Gimeno-Garcia AZ, Benitez-Zafra F, Hernandez A, Hernandez-Negrin D, Nicolas-Perez D, Hernandez G, Baute-Dorta JL, Cedres Y, Del-Castillo R, Mon J, Jimenez A, Navarro-Davila MA, Rodriguez-Hernandez E, Alarcon O, Romero R, Felipe V, Segura N, Hernandez-Guerra M. Agreement between the perception of colon cleansing reported by patients and colon cleansing assessed by a validated colon cleansing scale. Gastroenterol Hepatol. 2024 Feb;47(2):130-139. doi: 10.1016/j.gastrohep.2023.02.009. Epub 2023 Mar 2. English, Spanish.

  PMID: 36870478 DERIVED

• Gimeno-Garcia AZ, Hernandez G, Baute Dorta JL, Reygosa C, de la Barreda R, Hernandez-Bustabad A, Amaral C, Cedres Y, Del Castillo R, Nicolas-Perez D, Jimenez A, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez D, Ramos L, Carrillo M, Felipe V, Hernandez A, Rodriguez-Jimenez C, Quintero E. 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. Front Med (Lausanne). 2021 Mar 22;8:654847. doi: 10.3389/fmed.2021.654847. eCollection 2021.

  PMID: 33829030 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Goretti Hernandez, MD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only the endoscopists in charge of rating the bowel cleansing during the colonoscopy will be masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 5, 2019
• Study Start: February 4, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 30, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

ES (1)