Effect of Simethicone on Bowel Preparation for Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal
      visualization during colonoscopy is often limited by residual stool, bubbles, bile,
      intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other
      small lesions.Therefore, intestinal preparation is necessary to remove residual materials
      prior to endoscopy.

      A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution
      commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However,
      practitioners have noted an increased incidence of bubble formation with this preparation
      method.

      To the investigators knowledge, no previous study has assessed colon preparation in patients
      administered simethicone.

      The purpose of this study was to compare the quality of bowel preparation and compliance
      between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an
      antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel
      preparation scale and bubble score, and the compliance of both patients and endoscopists was
      also investigated using a questionnaire.
    

Detailed description: 
      1. Study design: endoscopist-blinded, prospective, randomized controlled trial

        2. Subjects

           - A single-center, randomized, observer-blinded study was performed at Korea University
           Hospital in Anam. Outpatients were prospectively enrolled. Each group of the patients
           will receive PEG-Asc or PEG-Asc with simethicone before colonoscopy.

        3. Sampling design: Consecutive recruitment of consenting patients

        4. Variables Predictor

             1. group 1 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before
                colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;

             2. group 2 (PEG-Asc with simethicone) received 1 L solution of PEG-Asc at 7 p.m the
                evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before
                procedure;Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last
                500 mL of additional clear fluid.

        5. Primary Outcome: Quality of bowel preparation [Boston Bowel Preparation Scale, bubble
           score]

        6. Secondary Outcome: Patients and endoscopists' compliance[Tolerability, palatability of
           patient, fatigue score of endoscopist]
    

Intervention name(s): PEG-Asc; PEG-Asc with simethicone
Intervention type(s): Drug; Drug
Intervention description(s): received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure; received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure. Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid.
Other intervention name(s): •Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea; Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Bowel preparation; Simethicone; Polyethylene glycol with ascorbic acid