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

Colonoscopy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685853
• Other study ID #: IEO S570 510
• Secondary ID: 2010-022967-37
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: September 18, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Evaluation of the quality of bowel preparation according to the Ottawa Scale	20 min	No
Secondary	Efficacy	Evaluation of the mucosal visibility according to a 3 point scale (0-2)	20 min	No
Secondary	Efficacy	Adenoma detection rate	20 min	No
Secondary	Safety	Recording of all adverse events occurred during the study by patient questioning	24 hours	Yes
Secondary	Tolerability	rate of patients in the two groups who developed GI symptoms related to bowel preparation	24 hours	No
Secondary	Acceptability	willingness to repeat the preparation	24 hours	No
Secondary	Compliance	rate of patient with intake of at least 75% of bowel preparation	24 hours	No