drugset / Trial / NCT04708366

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

NCT04708366

Phase 4 Unknown 846 enrolled University of Bologna
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-02-01
Primary completion
2022-03-15
Completion
2022-05-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moviprep Other / unclassified 2000 ml
Comparator Polyethylene glycol 400 Unknown 4000 ml
Subject polyethylene glycol Other / unclassified 1000 ml

Indications