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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.
Study design: endoscopist-blinded, prospective, randomized controlled trial
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.
Sampling design: Consecutive recruitment of consenting patients
Variables Predictor
Primary Outcome: Quality of bowel preparation [Boston Bowel Preparation Scale, bubble score]
Secondary Outcome: Patients and endoscopists' compliance[Tolerability, palatability of patient, fatigue score of endoscopist]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| the quality of the bowel preparation using Preparation Scale | Preparation Scale Preparation Scale | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of the bowel preparation | Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid. | 10 minutes |
| the patient's tolerability[questionnaire] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In kyung Yoo, MD | Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| In Kyung Yoo | Seoul | Anamdong 5-ga, Seongbuk-gu | 136-705 | South Korea |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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|
| 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. |
|
|
Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe". |
| 30 minutes before the colonoscopy |
| the endoscopist's tolerability[Visual Analog Score for fatigue] | Endoscopist fatigue during colonoscopy was scored using a Visual Analog Scale, ranging from 1-10, where 1 and 10 represented "strongly disagree" and "strongly agree", respectively. | 10 minutes |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |