Individualized Bowel Preparation for Colonoscopy

Phase 4

• Conditions: Colon Disease
• Interventions: Drug: Standard Preparation; Drug: Individualized Preparation

• Registration Number: NCT03428724
• Lead Sponsor: Clinical Hospital Colentina

Brief Summary

A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• elective out-patient diagnostic or therapeutic colonoscopy

Exclusion Criteria

• pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard group	Standard Preparation	standard polyethylene glycol preparation for colonoscopy
individualized group	Individualized Preparation	either a low or a high volume bowel preparation according to patient characteristics

Primary Outcome Measures

Name	Time	Method
bowel preparation quality	1-2 hours after completing bowel preparation	Boston bowel preparation score (BBPS)

Secondary Outcome Measures

Name	Time	Method
patient comfort during bowel preparation	1-2 hours after completing bowel preparation	0-10 patient comfort score using a standard visual-analogue scale

Trial Locations

Locations (2)

Colentina Clinical Hospital; 🇷🇴 Bucharest, Romania

Carol Davila Emergency Military Hospital; 🇷🇴 Bucharest, Romania