- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242369
Comparison of the Effectiveness of Bowel Preparations Before Colonoscopy
Comparison of the Effectiveness of Bowel Preparations in Bowel Cleansing Before Colonoscopy - Prospective, Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stepan Suchanek, MD., PhD.
- Phone Number: 00420 973208367
- Email: stepan.suchanek@uvn.cz
Study Contact Backup
- Name: Klara Kmochova, MD.,
- Phone Number: 00420 973203076
- Email: klara.kmochova@uvn.cz
Study Locations
-
-
-
Prague, Czechia, 16902
- Recruiting
- Military University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PEG group
100 patients undergoing 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.
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
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.
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
|
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.
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
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.
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.
|
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.
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
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.
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.
|
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.
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
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.
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)
Time Frame: 1 day
|
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of colorectal neoplasia
Time Frame: 1 day
|
In each colonoscopy the number of colorectal neoplasia will be rated. Colorectal neoplasia is defined by these two types of lession:
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Stepan Suchanek, MD., PhD., Military Univesity Hosital Prague
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108/11-29/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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