Clinical trial NCT04483037: Different Dosing Time of Bowklean for the Bowel Preparation
Official title: Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 297
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

Brief 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Aronchick Scale Bowel Cleaning Scale
timeFrame: during colonoscopy
Secondary outcomes:
measure: Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale
timeFrame: During Colonoscopy
measure: Colonscopy Bubble Scale
timeFrame: During Colonoscopy
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Hsu-Heng Yen
Study officials:
affiliation: Changhua Christian Hospital
name: HsuHeng Yen, MD
role: PRINCIPAL_INVESTIGATOR
References: