MedTrace Logo

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

NCT03146052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-05-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PEG-4000 added with citrates and simethicone (PEG-CS) plus Bisacodyl

PEG-4000 added with citrates and simethicone (PEG-CS) (Kit contains 4 pouches, each containing 64.5gr of PEG) and bisacodyl 5 mg tablets

Sponsors & Collaborators

  • ASST Rhodense

    lead OTHER

Principal Investigators

  • Gianpiero Manes · ASST Rhodense, Garbagnate Milanese, Lombardia, Italy, 20020

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03146052 on ClinicalTrials.gov