Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033250
• Other study ID #: 0117-19-RMB CTIL
• Status: Recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Rambam Health Care Campus
• Contact: Klein, MD
• Phone: +972-4-7773625
• Email: am_klein[@]rmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam MC	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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