Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Not Applicable

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

• Registration Number: NCT04033250
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Status Verified: 2019-09
• Study Start: 2019-09
• Last Update Submitted: 2019-09-22
• Last Update Posted: 2019-09-25
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional arm (group A)	Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure	Patients with risk factors for IBP who will receive "intensified" bowel preparation
Control arm (group B)	Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure	Patients with risk factors for IBP who will receive standard bowel preparation
Control arm (group c)	Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure	Patients without risk factors for IPB who will receive standard bowel preparation

Primary Outcome Measures

Name	Time	Method
Improved bowel preparation	Index colonoscopy	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.

Trial Locations

Locations (1)

Rambam MC; 🇮🇱 Haifa, Israel