Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

Phase 4

Active, not recruiting

• Conditions: Patients Undergoing Elective Colonoscopy
• Interventions: Drug: polyethylene glycole (PEG) solution; Drug: sodium picosulphate and magnesium citrate solution

• Registration Number: NCT01649674
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

• Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy

• Informed consent
• Age > 18 years

Exclusion Criteria

• Previous colonic resection
• Severe inflammatory bowel disease (IBD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG	polyethylene glycole (PEG) solution	polyethylene glycol solution 2 liters
NapP	sodium picosulphate and magnesium citrate solution	Sodium picosulphate and magnesium citrate solution 300 ml

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale value	at time of colonscopy	evaluated by two endoscopists who are blinded to treatment assigned at randomization
patient reported acceptability score	just prior to colonscopy	using visual analog scale

Secondary Outcome Measures

Name	Time	Method
percent of bowel cleansing regimen dose assumed as reported by patient	just prior to colonoscopy

Trial Locations

Locations (7)

Presidio Ospedaliero Villa d'Agri; 🇮🇹 Marsicovetere, Italy

AO Fatebenefratelli ed Oftalmico; 🇮🇹 Milano, Italy

A.O.U. Seconda Universita di Napoli; 🇮🇹 Napoli, Italy

Clinica Mediterranea; 🇮🇹 Napoli, Italy

Istituto Nazionale dei Tumori; 🇮🇹 Napoli, Italy

Presidio Ospedaliero Ascalesi; 🇮🇹 Napoli, Italy

Presidio Ospedaliero Maresca; 🇮🇹 Torre del Greco, Italy