Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial

Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.

The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.

Study Overview

• Status: Unknown
• Conditions: Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation
• Intervention / Treatment: Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klein, MD; Phone Number: +972-4-7773625; Email: am_klein@rmc.gov.il

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam MC

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:

• previous IBP
• concurrent medical conditions (e.g. diabetes, constipation)
• medications (e.g. opioids and tricyclic antidepressants)

Exclusion Criteria:

• previous colonic resection
• patients with IBD
• active CRC
• chronic kidney disease at any stage
• congestive heart failure at any stage
• liver cirrhosis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm (group A); Patients with risk factors for IBP who will receive "intensified" bowel preparation	Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure; Bowel preparation; Other Names: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses
Active Comparator: Control arm (group B); Patients with risk factors for IBP who will receive standard bowel preparation	Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure; Bowel preparation; Other Names: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses
Active Comparator: Control arm (group c); Patients without risk factors for IPB who will receive standard bowel preparation	Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure; Bowel preparation; Other Names: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved bowel preparation	Boston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment.	Index colonoscopy

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 22, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anticoagulants; Chelating Agents; Sequestering Agents; Cathartics; Laxatives; Calcium Chelating Agents; Antacids; Bisacodyl; Picosulfate sodium; Magnesium Oxide; Citric Acid; Sodium Citrate
• Other Study ID Numbers: 0117-19-RMB CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No