Comparison of the Effectiveness of Bowel Preparations Before Colonoscopy

Comparison of the Effectiveness of Bowel Preparations in Bowel Cleansing Before Colonoscopy - Prospective, Randomized Study

Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could be suitable substitution of polyethylene glycol.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Procedure: colonoscopy; Procedure: colonoscopy; Procedure: colonoscopy; Procedure: colonoscopy

Detailed Description

This study will be unicenter, randomized and single blind. It focuses on studying the effectiveness of four preparations for bowel cleansing before colonoscopy. Polyethylenglycol (PEG) will be compared as a gold standard of bowel cleansing with low volume preparations: Sulfate-based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric-acid and sodium picosulfate. The effectiveness will be rated according to a quality of bowel preparation (Boston Bowel Preparation Scale) and detection of a colorectal neoplasia. The aim of this project is to compare the effectiveness of each four preparations.

Primary endpoint: To compare a quality of bowel preparation. Secondary endpoint: To compare a detection of colorectal neoplasia in those preparations.

Main hypothesis: PEG as a gold standard of bowel cleansing preparation is not worse than the other compared preparations.

Secondary hypothesis: PEG is not worse in detection of colorectal neoplasia than the other compared preparations.

Methods: There will be 400 patients included in the project with all indications for colonoscopy (age ≥ 18 years, no upper age limit) except the exclusion criteria. The patients will be offered to participate in the study at the Endoscopy unit when arranging the examination. In case of agreement they will sign informed consent and they will be educated about the correct process of bowel preparation. They also get all the instructions in printed version and questionnaire of preparation tolerability. The advantages for the patients in study will be earlier date of colonoscopy. On the day of colonoscopy, the patients will submit the questionnaire and undergo standard colonoscopy examination.

The quality of a bowel cleansing will be evaluated by the experienced endoscopists who will be blinded about a type of bowel preparation. The effectiveness will be assessed by the degree of bowel cleansing (Boston Bowel Preparation Scale) and ADR, aADR and number of cancers diagnosed. The GE unit staff will record all results in the on-line study database. Results will be statistically evaluated in Institute of Biostatistics and Analyses, Masaryk University, IBA MU).

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 16902
    • Recruiting
    • Military University Hospital

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:

• Individuls ≥ 18 years old undergoing colonoscopy for all indications except exclusion criteria

Exclusion Criteria:

• Active idiopathic bowel disease
• Chronic renal insufficiency
• Serious internal comorbidity
• Planned therapeutic colonoscopy
• No informed consent signed (with the study and/or with the colonoscopy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEG group; 100 patients undergoing colonoscopy.	Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.
EXPERIMENTAL: SBS group; 100 patients undergoing colonoscopy	Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.
EXPERIMENTAL: PEG 2L + ascorbic acid group; 100 patients undergoing colonoscopy.	Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.
EXPERIMENTAL: PICO group; 100 patients undergoing colonoscopy.	Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.; Procedure: colonoscopy; 100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of bowel cleansing according to Boston Bowel Preparation Scale (BBPS)	0-Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1-Portion of mucosa of the colon segment seen, but other areas of the segment are not well seen due to staining, residual stool, and/or opaque liquid; 2-Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa colon segment is seen well; 3-Entire mucosa of colon segment seen well, with no residual staining, small fragment of stool or opaque liquid	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of colorectal neoplasia	In each colonoscopy the number of colorectal neoplasia will be rated. Colorectal neoplasia is defined by these two types of lession: advanced adenoma - 1cm size or greater or with villous component or with high grade dysplasia; carcinoma	1 day

Collaborators and Investigators

• Sponsor: Military University Hospital, Prague
• Collaborators: Masaryk University
• Investigators: Study Director: Stepan Suchanek, MD., PhD., Military Univesity Hosital Prague

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): March 31, 2019

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (ACTUAL): August 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; colorectal neoplasia; quality of bowel cleansing
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 108/11-29/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No