Individual Approach for Bowel Preparation Before Colonoscopy

NCT ID: NCT01476735

Last Updated: 2018-04-06

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

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.

Detailed Description

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Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.

Conditions

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Split-dose Bowel Preparation Polyethylene Glycol Solution Risk Factors Inadequate Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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split-dose polyethylene glycol solution

first dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy

Group Type ACTIVE_COMPARATOR

individual preparation for colonoscopy

Intervention Type OTHER

The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy

Individual preparation for colonoscopy

Group Type ACTIVE_COMPARATOR

individual preparation for colonoscopy

Intervention Type OTHER

The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy

Interventions

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individual preparation for colonoscopy

The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
* provided written informed consent

Exclusion Criteria

* lack of written informed consent or inability to provide informed consent or refusal to consent to the study
* pregnancy and breast feeding
* known allergy to PEG or bisakodyl
* presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
* colonoscopy performed under conscious sedation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaroslaw Regula, MD, PhD

Role: STUDY_DIRECTOR

Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland

Michal F. Kaminski, MD

Role: STUDY_CHAIR

Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland

Dorota Wretowska, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland

Locations

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Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Individual bowel preparation

Identifier Type: -

Identifier Source: org_study_id

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