Comparison of the Effectiveness of Bowel Preparations Before Colonoscopy
NCT ID: NCT03242369
Last Updated: 2018-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
400 participants
INTERVENTIONAL
2017-09-01
2019-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
NCT02956057
Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery
NCT02761317
Comparison Between Coolprep and Picolyte for Bowel Cleansing
NCT01774175
Comparison of Different Low Volume Solutions Prior to Colonoscopy
NCT03698474
Comparison of Bowel Cleansing Regimens Prior to Colonoscopy
NCT01649674
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEG group
100 patients undergoing colonoscopy.
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.
SBS group
100 patients undergoing colonoscopy
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
PEG 2L + ascorbic acid group
100 patients undergoing colonoscopy.
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.
PICO group
100 patients undergoing colonoscopy.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* Chronic renal insufficiency
* Serious internal comorbidity
* Planned therapeutic colonoscopy
* No informed consent signed (with the study and/or with the colonoscopy)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Masaryk University
OTHER
Military University Hospital, Prague
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stepan Suchanek, MD., Ph.D.
Head of Department of Gastrointestinal Endoscopy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stepan Suchanek, MD., PhD.
Role: STUDY_DIRECTOR
Military Univesity Hosital Prague
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Military University Hospital
Prague, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stepan Suchanek, MD., Ph.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
108/11-29/2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.