Comparing the Efficacy and Safety of Bowklean for the Bowel Preparation at Different Times

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    Changhua Christian Hospital
Updated on 28 July 2021

Summary

The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.

After bowel preparation, colonoscopy operator will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 3 treatment groups. The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon. Each subject's participation is expected to be maximally 3 weeks in study duration.

Description

The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.

After bowel preparation, colonoscopy operator will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 3 treatment groups. The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon. Each subject's participation is expected to be maximally 3 weeks in study duration.

Inclusion criteria:

  1. Subject is 20 and 99 years, inclusive.
  2. Men or non-pregnant women who are scheduled for an elective colonoscopy.
  3. Subjects should be willing, able to complete the entire procedure and to comply with study instructions.
  4. Written informed consent obtained prior to study.

Exclusion criteria:

  1. Patients who are not suitable for colonoscopy
    • Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
    • Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
    • Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo- obstruction, hypomotility syndrome)
    • Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus)
    • Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), arrhythmia, cardiomyopathy or uncontrolled hypertension
    • Renal insufficiency
  2. Any prior colorectal surgery
    • in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
    • History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
  3. Severe chronic constipation
  4. Hypersensitivity to any ingredient in the study medication

Details
Condition Bowel Preparation
Treatment Bowklean
Clinical Study IdentifierNCT04483037
SponsorChanghua Christian Hospital
Last Modified on28 July 2021

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