Quality of Bowel Preparation
Conditions
Keywords
simethicone, Boston Bowel Preparation Scale (BBPS), bubble score, Colon Endoscopic Bubble Scale（CEBuS), adenoma detection rate (ADR), water-exchange (WE) colonoscopy
Brief summary
Background: Colonoscopy reduces colorectal cancer mortality by enabling early detection and removal of adenomas. Its effectiveness, however, depends heavily on bowel preparation quality and mucosal visibility. Simethicone, an anti-foaming agent, decreases intraluminal bubbles and improves visualization; studies in conventional air-insufflation colonoscopy generally show benefits for cleanliness and patient comfort, but evidence in water-exchange (WE) colonoscopy remains limited.Objective: To evaluate whether adding oral simethicone to a split-dose polyethylene glycol (PEG) regimen further improves bowel cleanliness and procedural performance in WE colonoscopy.Methods: Adults undergoing outpatient colonoscopy will be randomly assigned (1:1) to a simethicone group or a control group, with a planned enrollment of 180 participants. All procedures will use the WE insertion technique, and endoscopists will be blinded to group allocation. The primary endpoint is the Boston Bowel Preparation Scale (BBPS); adequate preparation is defined as a total score ≥6 with all segment scores ≥2. Secondary endpoints include bubble score and CEBuS, adenoma detection rate (ADR), polyp detection rate (PDR), cecal intubation rate and time, withdrawal time, volume of water used and flushing/irrigation metrics, and patient-reported tolerability and satisfaction.Expected Results: Compared with PEG alone, adding simethicone is expected to (1) increase the proportion of adequate BBPS preparations, (2) reduce bubble coverage, (3) maintain or potentially improve ADR/PDR, and (4) enhance patient tolerability and satisfaction.Conclusion: If effective, this intervention would provide a simple, low-cost strategy to optimize the quality of WE colonoscopy.
Interventions
DRUGSimethicone with PEG
All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen. Participants in the simethicone group additionally received 30 mL of simethicone (600 mg), with 15 mL added to each 1-liter dose of PEG solution.
DRUGPEG
All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen.
Sponsors
Dalin Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Consecutive patients undergoing screening, surveillance, or diagnostic colonoscopy. * Procedures performed by participating endoscopists. * Ability to provide written informed consent.
Exclusion criteria
* Colonoscopy performed using air insufflation or water immersion technique. * History of colorectal surgery (e.g., colectomy or colostomy). * Known or suspected colonic obstruction or severe stricture. * Requirement for inpatient bowel preparation. * Known allergy or hypersensitivity to simethicone. * Unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston bowel preparation scale (BBPS) | At the time of colonoscopy. | Bowel preparation quality assessed using the Boston Bowel Preparation Scale (BBPS). Adequate preparation is defined as a total score ≥6 with all segment scores ≥2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bubble score assessed using a 4-point bubble scale | During the colonoscopy procedure. | Bubble score assessed during colonoscopy using a 4-point scale (0-3) for each colon segment, where higher scores indicate more bubbles. |
| Colon Endoscopic Bubble Scale(CEBuS) | During the colonoscopy procedure. | Bowel cleanliness assessed using the Colon Endoscopic Bubble Scale (CEBuS), categorized based on the percentage of mucosal surface obscured by bubbles (e.g., \<5%, 5-50%, \>50%).Higher scores indicate poorer visibility due to bubbles. |
| Adenoma detection rate (ADR) | one week | — |
| Polyp detection rate (PDR) | one week | — |
| Cecal intubation rate | At the time of colonoscopy. | Proportion of procedures in which the cecum is successfully reached. |
| Cecal intubation time | During the colonoscopy procedure. | Time from insertion to successful cecal intubation, measured in minutes. |
| Withdrawal time | During the colonoscopy procedure. | Time from cecal intubation to scope withdrawal, measured in minutes. |
| Volume of water infused | During the procedure. | Total volume of water infused during colonoscopy, measured in milliliters. |
| Volume of fluid aspirated | During the procedure | Total volume of fluid aspirated during colonoscopy, measured in milliliters. |
| Patient-reported pain score | Immediately after the procedure. | Pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). |
| Patient satisfaction score | Immediately after the procedure. | Patient satisfaction assessed using a numeric rating scale from 0 to 10, where higher scores indicate greater satisfaction. |
Contacts
CONTACTChih -Wei Tseng
Outcome results
None listed