Effect of Simethicone on Bowel Preparation for Colonoscopy

NCT02548403 | Completed Phase 3 DMC

• 1 other identifier: Korea University Prep1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Bowel preparation; Simethicone; Polyethylene glycol with ascorbic acid

Outcome Measures

Primary Outcomes (1)

• the quality of the bowel preparation using Preparation Scale

  Preparation Scale Preparation Scale

  20 minutes

Secondary Outcomes (3)

• Completeness of the bowel preparation

  10 minutes

• the patient's tolerability[questionnaire]

  30 minutes before the colonoscopy

• the endoscopist's tolerability[Visual Analog Score for fatigue]

  10 minutes

Study Arms (2)

PEG-Asc

ACTIVE COMPARATOR

group 1 (PEG-Asc, N=130) 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

Drug: PEG-Asc; Drug: PEG-Asc with simethicone

PEG-Asc with simethicone

ACTIVE COMPARATOR

group 2 (PEG-Asc with simethicone, N=130) 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.

Drug: PEG-Asc; Drug: PEG-Asc with simethicone

Interventions

PEG-Asc DRUG

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

Also known as: •Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea

PEG-Asc; PEG-Asc with simethicone

PEG-Asc with simethicone DRUG

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.

Also known as: Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea

PEG-Asc; PEG-Asc with simethicone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients,
• aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study

You may not qualify if:

• patients who had chronic kidney disease,
• severe heart failure(New York Heart Association \[NYHA\] class III or IV)
• uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg)
• severe constipation
• any bowel resection
• significant gastroparesis, or
• suspected bowel obstruction or perforation.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

In Kyung Yoo

Seoul, Anamdong 5-ga, Seongbuk-gu, 136-705, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• In kyung Yoo, MD

  Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 14, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 14, 2015

Record last verified: 2015-09

Locations

KR (1)