drugset / Trial / NCT03146052

Comparison Between Asymmetric And Standard Split-Dose Regimen For Bowel Preparation

NCT03146052

Completed 81 enrolled ASST Rhodense
RandomizedParallel-groupSingle-blindTreatment

Summary

We aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the procedure and 75% of the dose is given on the day before) with the standard split-dose regimen in patients undergoing screening and surveillance colonoscopy using a low volume bowel preparation (2L PEG-citrate-simethicone plus Bisacodyl). We enrolled consecutive outpatients undergoing screening and surveillance colonoscopy in a randomized, single-blind, non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split dose regimen (1,5 L of PEG + bisacodyl the day before and 0,5 L 4 hours before colonoscopy); group B, symmetric split dose regimen (1 L of PEG + bisacodyl the day before and 1 L 5 hours before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing. Moreover, all patients filled in a nurse-administered questionnaire assessing compliance, tolerability and safety of bowel preparation.

Timeline

Start
2017-03-27
Primary completion
2017-05-05
Completion
2017-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG 4000 Unknown 258 g Oral
Subject Simethicone Other / unclassified Oral
Background Bisacodyl Small molecule 20 mg Oral

Indications