Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Boston bowel preparation scale (BBPS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients undergoing screening, surveillance, or diagnostic colonoscopy.
- •Procedures performed by participating endoscopists.
- •Ability to provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
With simethicone group
Participants received a total of 30 mL of simethicone, with 15 mL added to each 1-liter dose of polyethylene glycol (PEG) solution in the split-dose regimen.
干预措施: Simethicone with PEG (Drug)
Without simethicone group
follow a bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution.
干预措施: PEG (Drug)
结局指标
主要结局
Boston bowel preparation scale (BBPS)
时间窗: 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.
次要结局
- Volume of water infused(During the procedure.)
- Bubble score assessed using a 4-point bubble scale(During the colonoscopy procedure.)
- Volume of fluid aspirated(During the procedure)
- Colon Endoscopic Bubble Scale(CEBuS)(During the colonoscopy procedure.)
- Adenoma detection rate (ADR)(one week)
- Polyp detection rate (PDR)(one week)
- Cecal intubation rate(At the time of colonoscopy.)
- Cecal intubation time(During the colonoscopy procedure.)
- Withdrawal time(During the colonoscopy procedure.)
- Patient-reported pain score(Immediately after the procedure.)
- Patient satisfaction score(Immediately after the procedure.)