Individual Approach for Bowel Preparation Before Colonoscopy

A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Split-dose Bowel Preparation; Polyethylene Glycol Solution; Risk Factors Inadequate Preparation
• Intervention / Treatment: Other: individual 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 Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-781
    • Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Other: 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
ACTIVE_COMPARATOR: Individual preparation for colonoscopy	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the index of preparation quality for the whole colon	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	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance safety	number of patients with completion of preparation number of patients with side effects of preparation in each group	24 hours

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Investigators: Study Director: Jaroslaw Regula, MD, PhD, Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland; Study Chair: Michal F. Kaminski, MD, Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland; Principal Investigator: Dorota Wretowska, MD, Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (ESTIMATE): November 22, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: Individual bowel preparation