Impact of a Predictive Score of Bowel Preparation Quality in Clinical Practice (REPREP2)

Intensive High-volume Bowel Cleansing Regimen Versus Low-volume Bowel Regimen in Patients With a High Risk of Poor Colonic Cleansing Following a Validated Predictive Score

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.

Study Overview

• Status: Completed
• Conditions: Cleansing Quality of the Colon
• Intervention / Treatment: Drug: polyethylene glycol; Drug: polyethylene glycol plus ascorbic acid

Detailed Description

This is a prospective, randomized, single-blind phase IV study in which all outpatients scheduled for a colonoscopy will be given a different bowel cleansing strategy (conventional or intensified) according to a scoring system already validated in the investigator's center, designed with variables independently associated with poor bowel cleansing, constipation, abdominal/pelvic surgery, comorbidity and to be on antidepressant treatment. According to this system, a score equal to or less than 1.225, predicts with a high confidence (negative predictive value = 88%) a suitable cleansing quality with a standard preparation protocol. Therefore, these subjects will be advised of a conventional preparation (low fiber diet the day before the examination and low volume preparation consisting of 2 L of PEG with ascorbic acid). Subjects with a score greater than 1.225 will be randomized to receive an intensive bowel preparation (low fiber diet three days prior to colonoscopy and large bowel preparation consisting of 4 L PEG with bisacodyl) or a conventional one (low fiber diet the day before the examination and 2 L of PEG with ascorbic acid). The choice of low-volume preparation as a control is supported by the absence of significant differences in quality of cleanliness in patients with a score > 1.225 among patients prepared with high or low volume and that low volume preparation appears to improve tolerance and compliance.

A researcher will offer to participate in the study to all outpatients with a scheduled colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the bowel preparation strategy. Thus, according to the allocation group, participants must comply with a large volume cleansing strategy or a conventional one. For patients with a low score (≤ 1.225) a conventional preparation will be recommended.

Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.

The hypothesis of the study is that in patients with a high risk of poor bowel preparation, the large bowel based preparation strategy is superior to the conventional bowel preparation in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • S/C De Tenerife
    • La Laguna, S/C De Tenerife, Spain, 38320
      • Department of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Large volume based preparation; 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; The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet
Active Comparator: Low volume based preparation; 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; The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of polyps detected in each arm	Number of polyps in one arm/total of polyps detected	8 months
Tolerance to bowel preparation	It will be subjective and assessed by a visual analog scale (0 very bad, 10 excellent)	8 months

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias
• Investigators: Principal Investigator: Goretti Hernandez, MD, Hospital Universitario de Canarias

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Colonoscopy; Cleansing quality score
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: Score-guided colon cleansing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No