Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
- Conditions
- Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Improved bowel preparation
- Last Updated
- 6 years ago
Overview
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.
Investigators
Amir Klein MD
Principal Investigator
Rambam Health Care Campus
Eligibility Criteria
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
Arms & Interventions
Interventional arm (group A)
Patients with risk factors for IBP who will receive "intensified" bowel preparation
Intervention: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
Control arm (group B)
Patients with risk factors for IBP who will receive standard bowel preparation
Intervention: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
Control arm (group c)
Patients without risk factors for IPB who will receive standard bowel preparation
Intervention: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
Outcomes
Primary Outcomes
Improved bowel preparation
Time Frame: 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.