Comparison of the Effectiveness of Bowel Preparations Before Colonoscopy
1 other identifier
interventional
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedFebruary 1, 2018
January 1, 2018
1.3 years
July 18, 2017
January 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Detection of colorectal neoplasia
1 day
Study Arms (4)
PEG group
EXPERIMENTAL100 patients undergoing colonoscopy.
SBS group
EXPERIMENTAL100 patients undergoing colonoscopy
PEG 2L + ascorbic acid group
EXPERIMENTAL100 patients undergoing colonoscopy.
PICO group
EXPERIMENTAL100 patients undergoing colonoscopy.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Military University Hospital, Praguelead
- Masaryk Universitycollaborator
Study Sites (1)
Military University Hospital
Prague, 16902, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stepan Suchanek, MD., PhD.
Military Univesity Hosital Prague
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Gastrointestinal Endoscopy
Study Record Dates
First Submitted
July 18, 2017
First Posted
August 8, 2017
Study Start
September 1, 2017
Primary Completion
December 31, 2018
Study Completion
March 31, 2019
Last Updated
February 1, 2018
Record last verified: 2018-01