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NCT03849196 Clinical Trial

Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG

Bowel Preparation Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03849196
Other study ID # 2017-05-100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2017
Est. completion date January 30, 2018

Study information
Verified date February 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.

Outcome measures: the Boston Bowel Preparation Scale (BBPS)

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date January 30, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- outpatients who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion Criteria:

- History of gastrointestinal tract surgery

- History of inflammatory bowel disease

- History of severe active colitis

- History of chronic kidney disease

- pregnant woman.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 2L PEG-Asc
PEG-Asc powder
• Bisacodyl 10Mg Suppository
bisacodyl 10 mg suppository
• 1L PEG-Asc
PEG-Asc powder

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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