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

Not Applicable

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: 2L PEG-Asc; Drug: Bisacodyl 10Mg Suppository; Drug: 1L PEG-Asc

• Registration Number: NCT03849196
• Lead Sponsor: Samsung Medical Center

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.

Detailed 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)

Study Timeline

• Study Start: 2017-07-31
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2019-02
• Study First Submitted: 2019-02-16
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2L PEG-Asc	2L PEG-Asc	2L PEG-Asc for bowel preparation
1L PEG-Asc & 'Bisacodyl 10Mg Suppository	Bisacodyl 10Mg Suppository	1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation
1L PEG-Asc & 'Bisacodyl 10Mg Suppository	1L PEG-Asc	1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale (BBPS).	1 hour	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)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of