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

Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: PEG 4 litres split; Drug: Bisacodyl plus PEG-CS

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20141
    • European Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEG 4 litres split; Polyethylene glycol with electrolytes (PEG)	Drug: PEG 4 litres split; the day before colonoscopy: 2 litres of PEG; the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination; Other Names: SELG 1000
Experimental: Bisacodyl plus PEG-CS; Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)	Drug: Bisacodyl plus PEG-CS; the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime; the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam; Other Names: LOVOLdyl plus LOVOLesse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Evaluation of the quality of bowel preparation according to the Ottawa Scale	20 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Evaluation of the mucosal visibility according to a 3 point scale (0-2)	20 min
Efficacy	Adenoma detection rate	20 min
Safety	Recording of all adverse events occurred during the study by patient questioning	24 hours
Tolerability	rate of patients in the two groups who developed GI symptoms related to bowel preparation	24 hours
Acceptability	willingness to repeat the preparation	24 hours
Compliance	rate of patient with intake of at least 75% of bowel preparation	24 hours

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Cristiano Crosta, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 13, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: IEO S570 510; 2010-022967-37 (EudraCT Number)