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

Phase 4

Completed

• Conditions: Bowel Cleansing Process; Colonoscopy
• Interventions: Drug: Standard approach; Drug: Individualized approach

• Registration Number: NCT02024022
• Lead Sponsor: Clinical Hospital Colentina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2013-12-31
• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard approach	Standard approach	patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic: * 4L split polyethylene glycol solution * split magnesium citrate/sodium picosulphate preparation regimen
Individualized approach	Individualized approach	patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level)

Primary Outcome Measures

Name	Time	Method
bowel cleansing	24 hours	bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)

Secondary Outcome Measures

Name	Time	Method
patient comfort level during bowel cleansing	24 hours	patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process

Trial Locations

Locations (3)

Colentina Clinical Hospital; 🇷🇴 Bucharest, Romania

Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor; 🇷🇴 Cluj, Romania

Spitalul CFR; 🇷🇴 Cluj, Romania