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Efficacy And Tolerability Of Asymmetric Split Regimen For Bowel Preparation

NCT06916689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2025-04-13

No results posted yet for this study

Summary

The investigators 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 very low volume bowel preparation (1L PEG+Ascorbate). Consecutive outpatients undergoing screening and surveillance colonoscopy were enrolled in a randomized, single-blind, non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split dose regimen (0,75 L of PEG + ASC the day before and 0,25 L 2:30 hours before colonoscopy); group B, symmetric split dose regimen (0,5 L of PEG + ASC the day before and 0,5 L 3 hours before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing. Moreover, all patients filled in a validated, nurse-administered questionnaire assessing compliance, tolerability and safety of bowel preparation.

Conditions

  • Colon Preparation
  • Polyps Colorectal

Interventions

DRUG

1L PEG-Asc

PEG 3350 plus sodium sulfate plus sodium chloride plus potassium chloride plus ascorbic acid plus sodium ascorbate

Sponsors & Collaborators

  • ASST Rhodense

    lead OTHER

Principal Investigators

  • Gianpiero Manes · ASST Rhodense

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2024-10-10
Completion
2024-10-10

Countries

  • Italy

Study Locations

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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 NCT06916689 on ClinicalTrials.gov