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Completed

NCT Number: NCT04483037

Different Dosing Time of Bowklean for the Bowel Preparation

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.

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Key information

Conditions

Bowel Preparation

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hsu-Heng Yen

Changhua, 500, Taiwan

About this study

Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy.

This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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)
  • Severe chronic constipation
  • Hypersensitivity to any ingredient in the study medication

Treatment and study plan

Bowklean

Drug

assigned intervention

Primary outcomes

  1. Aronchick Scale Bowel Cleaning Scale

    Time frame: during colonoscopy

    Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed

Secondary outcomes

  1. Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale

    Time frame: During Colonoscopy

    The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3

  2. Colonscopy Bubble Scale

    Time frame: During Colonoscopy

    Colon Bubble Scale : Grade A : no bubble , Grade B: little bubble , Grade C: bubble of half of the lumen , Grade D: bubble of entire lumen. Grade A means the best and Grade D means the worst.

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2020
Registry last updated
Jul 23, 2021

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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