Individual Approach for Bowel Preparation Before Colonoscopy

Not Applicable

Completed

• Conditions: Risk Factors Inadequate Preparation; Split-dose Bowel Preparation; Polyethylene Glycol Solution
• Interventions: Other: individual preparation for colonoscopy

• Registration Number: NCT01476735
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-08
• Status Verified: 2011-11
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
split-dose polyethylene glycol solution	individual preparation for colonoscopy	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
Individual preparation for colonoscopy	individual preparation for colonoscopy	-

Primary Outcome Measures

Name	Time	Method
the index of preparation quality for the whole colon	24 hours	the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale

Secondary Outcome Measures

Name	Time	Method
compliance safety	24 hours	number of patients with completion of preparation number of patients with side effects of preparation in each group

Trial Locations

Locations (1)

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