A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy

Phase 4CompletedNCT02024022

Clinical Hospital Colentina185 enrolled

Overview

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

185

Conditions

Bowel Cleansing Process Colonoscopy

Interventions

Standard approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * all patients \> 18 years of age undergoing elective colonoscopy on an outpatient basis Exclusion Criteria: * refusal to sign informed consent * pregnancy * advance kidney, liver or heart disease * suspicion of malignant / benign stenosis of the digestive tract

Locations (3)

Colentina Clinical Hospital

Bucharest, Romania

Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor

Cluj-Napoca, Romania

Spitalul CFR

Cluj-Napoca, Romania

Outcomes

Primary Outcomes

bowel cleansing

bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)

Time frame: 24 hours

Secondary Outcomes

patient comfort level during bowel cleansing

patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process

Time frame: 24 hours