Effect of an Individualized Non-pharmacological Intervention Based on a Predictive Model for Inadequate Bowel Preparation on Bowel Preparation Quality: a Three-arm, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- Bowel preparation quality
研究概览
简要总结
Colonoscopy is essential for the early detection of colorectal cancer. However, inadequate bowel preparation remains a common challenge, associated with reduced adenoma detection rates, prolonged procedure time, and increased healthcare costs. Current individualized regimens rely largely on higher laxative dosages-an approach with limited clinical utility. Non-pharmacological interventions, including dietary modification, physical activity, and health education, are safe and tend to have better patient adherence. The effectiveness of health education depends largely on message framing. Guided by information-framing theory, we developed an individualized non-pharmacological regimen. This randomized controlled trial aims to evaluate the efficacy of this regimen in improving bowel preparation quality.
详细描述
A total of 339 patients are enrolled and randomly assigned in a 1:1:1 ratio to the information-framing + individualized bowel preparation (BP) group, the individualized BP group, and the control group. All patients receive oral instructions on bowel preparation. On this basis, the control group receives a standard BP regimen and written educational materials; the individualized BP group is assessed using a risk prediction model for inadequate bowel preparation, with the results disclosed to the patients. Those with a risk score ≥3.25 receive an enhanced BP regimen, while those with a risk score <3.25 receive the standard BP regimen, and all patients in this group receive illustrated educational materials. In the information-framing + individualized BP group, educational materials are further tailored according to the information framework theory. Specifically, patients with a risk score ≥3.25 receive loss-framed materials emphasizing the harms of non-adherence, whereas those with a score <3.25 receive gain-framed materials highlighting the benefits of adherence. On the day of the colonoscopy, patients' willingness to undergo a repeat colonoscopy and the occurrence of adverse events are recorded in the waiting area. Patients also complete the Bowel Preparation Adherence Behavior Assessment Scale and the Treatment Self-Regulation Questionnaire. Bowel preparation quality is evaluated by endoscopists blinded to group allocation using the Boston Bowel Preparation Scale (BBPS), and polyp/adenoma detection rates are also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years;
- •outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
- •able to understand the study and provide written informed consent.
排除标准
- •undergoing emergency colonoscopy;
- •suspected intestinal obstruction, stricture, or perforation;
- •severe cardiac, cerebral, hepatic, or renal disease;
- •severe psychiatric disorder;
- •impaired consciousness or communication difficulties;
- •pregnancy or lactation;
- •previous enrollment in this study.
结局指标
主要结局
Bowel preparation quality
时间窗: Assessed by the endoscopist during colonoscopy procedure
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (BBPS). Bowel preparation was considered adequate when the total BBPS score was ≥ 6, with each colonic segment score ≥ 2.
次要结局
- Incidence of bowel preparation-related adverse events(Recorded during the waiting period prior to colonoscopy procedure)
- Polyp/adenoma detection rate(Assessed by the endoscopist during colonoscopy procedure)
- Compliance of bowel preparation(Assessed during the waiting period prior to colonoscopy procedure)
- Willingness to undergo colonoscopy again (yes/no)(Assessed during the waiting period prior to colonoscopy procedure)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region