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Completed

NCT Number: NCT03849196

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

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.

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Key information

Conditions

Bowel Preparation

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2L PEG-Asc

Drug

PEG-Asc powder

Other names: clicool, coolprep

Bisacodyl 10Mg Suppository

Drug

bisacodyl 10 mg suppository

1L PEG-Asc

Drug

PEG-Asc powder

Other names: clicool, coolprep

Primary outcomes

  1. Boston Bowel Preparation Scale (BBPS).

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 21, 2019
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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