Multi-centre Failed Bowel Prep RCT

• Status: Completed
• Trial end date: 2020-02-19
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre randomized clinical trial comparing the efficacy of two different bowel preparation regimens for patients who have already failed a bowel preparation for colonoscopy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: Academic Medical Organization of Southwestern Ontario; McGill University; Pendopharm; Université de Montréal; University of Alberta; University of Western Ontario, Canada
• Treatments: Bisacodyl

Criteria

Inclusion Criteria:

1. Anyone undergoing a repeat colonoscopy due to failed bowel preparation at index colonoscopy. Failure is defined as preparation quality inadequate to detect lesions > 5 mm after washing and requiring a shortened colonoscopy interval as a result.

2. Age > 18 years

3. Outpatient colonoscopy

4. Indication for full colonoscopy

Exclusion Criteria:

1. Subject refusal

2. Able to comprehend the trial

3. Index colonoscopy performed as an inpatient

4. Pregnancy or breastfeeding

5. Allergies to the employed bowel preparations

6. Any colonic surgery

7. History of ischemic colitis

8. Congestive heart failure

9. Chronic renal failure

10. Cirrhosis

11. Severe electrolyte imbalance

12. Non-adherence to index bowel preparation defined as failure to follow diet instructions and/or consume the entire volume of bowel preparation medication as prescribed for any reason (ex. eating a normal diet on the day of colonoscopy, PEG intolerance, etc…)

13. Use of bowel preparation in an off-label manner for the index colonoscopy.

14. Inability to follow verbal and written instructions in English or French.

15. Ileus, gastric outlet obstruction, gastrointestinal obstruction, bowel preforation

16. Toxic coitis or toxic megacolon

17. Acute surgical abdomen including appendicitis

18. Gastroenteritis and acute diverticulitis