Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients

• Status: Not yet recruiting
• Trial end date: 2022-05-15
• Target enrollment: 0
• Participant gender: All

Summary

An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.

Aim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna

Criteria

Inclusion Criteria:

• Inpatients scheduled for elective colonoscopy

• bowel preparation performed inside the hospital

• ≥18 years old

Exclusion Criteria:

• known or suspected ileus

• gastrointestinal obstruction

• gastric retention

• bowel perforation

• toxic colitis, or megacolon

• phenylketonuria

• glucose-6-phosphate dehydrogenase deficiency

• active intestinal bleeding

• emergency colonoscopy

• dementia or illness requiring nasogastric tube for bowel prep administration

• refusal to participate or inability to sign the informed consent