Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One

Phase 3

Completed

• Conditions: Colonoscopy
• Interventions: Drug: PEG 4 litres split; Drug: Bisacodyl plus PEG-CS

• Registration Number: NCT01685853
• Lead Sponsor: European Institute of Oncology

Brief Summary

The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.

Detailed Description

Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-14
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Out-patients undergoing a complete colonoscopy
• Patient written informed consent

Exclusion Criteria

• Pregnant or lactating women or at a risk of becoming pregnant
• Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG 4 litres split	PEG 4 litres split	Polyethylene glycol with electrolytes (PEG)
Bisacodyl plus PEG-CS	Bisacodyl plus PEG-CS	Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)

Primary Outcome Measures

Name	Time	Method
Efficacy	20 min	Evaluation of the quality of bowel preparation according to the Ottawa Scale

Secondary Outcome Measures

Name	Time	Method
Efficacy	20 min	Adenoma detection rate
Safety	24 hours	Recording of all adverse events occurred during the study by patient questioning
Tolerability	24 hours	rate of patients in the two groups who developed GI symptoms related to bowel preparation
Acceptability	24 hours	willingness to repeat the preparation
Compliance	24 hours	rate of patient with intake of at least 75% of bowel preparation

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy