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

NCT ID: NCT01685853

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PEG 4 litres split

Polyethylene glycol with electrolytes (PEG)

Group Type ACTIVE_COMPARATOR

PEG 4 litres split

Intervention Type DRUG

* the day before colonoscopy: 2 litres of PEG
* the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination

Bisacodyl plus PEG-CS

Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)

Group Type EXPERIMENTAL

Bisacodyl plus PEG-CS

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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LOVOLdyl plus LOVOLesse SELG 1000

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cristiano Crosta, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2010-022967-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IEO S570 510

Identifier Type: -

Identifier Source: org_study_id