Different Dosing Time of Bowklean for the Bowel Preparation

Phase 4

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: Bowklean

• Registration Number: NCT04483037
• Lead Sponsor: Changhua Christian Hospital

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).

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
split dose, day before, colonoscopy in the morning (Observation Group)	Bowklean	routine bowel preparation before colonoscopy in the morning
split dose, day before, colonoscopy in the afternoon (Random)	Bowklean	routine bowel preparation before colonoscopy in the afternoon
two dose in the same day, colonoscopy in the afternoon (Random)	Bowklean	experimental group

Primary Outcome Measures

Name	Time	Method
Aronchick Scale Bowel Cleaning Scale	during colonoscopy	Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed

Secondary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale	During Colonoscopy	The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3
Colonscopy Bubble Scale	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.

Trial Locations

Locations (1)

Hsu-Heng Yen; 🇨🇳 Changhua, Taiwan