Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG
Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study
1 other identifier
interventional
168
1 country
1
Brief Summary
Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2018
CompletedFirst Submitted
Initial submission to the registry
February 16, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedFebruary 21, 2019
February 1, 2019
6 months
February 16, 2019
February 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Boston Bowel Preparation Scale (BBPS).
4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum)
1 hour
Study Arms (2)
2L PEG-Asc
EXPERIMENTAL2L PEG-Asc for bowel preparation
1L PEG-Asc & 'Bisacodyl 10Mg Suppository
ACTIVE COMPARATOR1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation
Interventions
PEG-Asc powder
Eligibility Criteria
You may qualify if:
- outpatients who were scheduled for colonoscopy between August 2017 and January 2018
You may not qualify if:
- History of gastrointestinal tract surgery
- History of inflammatory bowel disease
- History of severe active colitis
- History of chronic kidney disease
- pregnant woman.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
brian.biochem@gmail.com Kim
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical associate professor
Study Record Dates
First Submitted
February 16, 2019
First Posted
February 21, 2019
Study Start
July 31, 2017
Primary Completion
January 30, 2018
Study Completion
January 30, 2018
Last Updated
February 21, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share