NCT01685853

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-09-14
• Last updated: 2012-09-19

Locations

1 site across 1 country: Italy