Impact of App-Based Education and Low-Residue Diet Approaches on Colonoscopy Preparation in Naive Patients: A Randomized, Evaluator-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 主要终点
- Percentage of subjects that achieve adequate cleansing
研究概览
简要总结
This prospective, randomized, evaluator-blind, parallel-group trial is designed to objectively compare the effectiveness of Advanced Bowel Preparation versus Traditional Bowel Preparation in patients undergoing colonoscopy. In this study, "naive patients" are defined as individuals who have never used Bowklean® as a bowel cleansing agent, or those who may have previously used other bowel preparation regimens but have not undergone any bowel cleansing procedure within the past three years. The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low residue dietary restrictions. In contrast, the Advanced Bowel Preparation integrates a smartphone based educational app with a Prepackaged Low-Residue Diet. All participants will use Bowklean®, a bowel preparation agent combining sodium picosulfate, magnesium oxide, and anhydrous citric acid.
The primary endpoint is the percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS).
The secondary endpoints include the percentage of subjects that achieve excellent cleansing (score ≧ 8) in the BBPS, mean score in different colon segments (right, transverse, left), which are assessed with the BBPS, adenoma detection rate, sessile serrated polyp detection rate, and patient satisfaction.
详细描述
Bowel preparation is a important task for colonoscopy examination. Studies have demonstrated that using smartphone apps can improve patient compliance and the quality of bowel cleansing. Additionally, the use of prepackaged low residue diet (PLD) has become increasingly common. PLD are designed to minimize undigested food residue in the gut, facilitating a cleaner colon for procedures like colonoscopy. Implementing PLD can reduce the burden of dietary restrictions on patients and enhance the effectiveness of bowel preparation. This study aims to evaluate whether an advanced bowel preparation protocol that combines a smartphone application with a PLD can improve patient satisfaction, and the cleanliness of the colon compared to standard preparation methods.
This prospective, randomized, evaluator-blind, parallel-group trial is designed to objectively compare the effectiveness of Advanced Bowel Preparation versus Traditional Bowel Preparation in patients undergoing colonoscopy. In this study, "naive patients" are defined as individuals who have never used Bowklean® as a bowel cleansing agent, or those who may have previously used other bowel preparation regimens but have not undergone any bowel cleansing procedure within the past three years. The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low residue dietary restrictions. In contrast, the Advanced Bowel Preparation integrates a smartphone based educational app (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD). All participants will use Bowklean®, a bowel preparation agent combining sodium picosulfate, magnesium oxide, and anhydrous citric acid. Blinding of outcome evaluators (endoscopists) helps minimize assessment bias, while the randomized parallel-arm design supports robust group comparisons. This design allows a focused assessment of whether combining digital and dietary support can improve bowel cleanliness, detection outcomes, and patient satisfaction. Overall, this trial structure is intended to generate clinically relevant, real-world evidence on optimizing colonoscopy preparation by integrating pharmacologic, digital, and dietary strategies.
Primary Endpoint:
The percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS).
The secondary endpoints include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 75 years of age.
- •Bowklean naive patient with no bowel preparation in 3 years.
- •The subject is scheduled for a colonoscopy.
- •Ability to complete the entire procedure and to comply with study instructions.
- •Willingness and ability to provide signed informed consent.
排除标准
- •1. Patients who are unsuitable for Bowklean use due to known contraindications, including but not limited to:
- •Allergies or hypersensitivity to Bowklean or its ingredients.
- •Severe gastrointestinal conditions (e.g., obstruction, perforation).
- •Renal impairment or electrolyte imbalances (e.g., severe hyponatremia).
- •Gastrointestinal surgery affects bowel preparation.
- •Patients deemed medically unsuitable for colonoscopy by the physician.
- •Cognitive, language, or other barriers that prevent completion of the questionnaire.
- •4. Non-compliance with the bowel preparation protocol or inability to follow dietary restrictions (e.g., Prepackaged low residue diet, PLD).
- •5. Inability to use or access the mobile APP (e.g., no smartphone, unfamiliarity with APP operations, or technical limitations).
- •6. Participation in other clinical trials.
研究组 & 干预措施
Traditional Bowel Preparation
The Traditional Bowel Preparation approach consists of standard paper-based educational handouts and self-managed low-residue dietary restrictions.
Advanced Bowel Preparation
Advanced Bowel Preparation integrates a smartphone-based educational app (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD).
干预措施: Tian Tian Yi Chi go APP (developed by UIC Corp) (Device)
Advanced Bowel Preparation
Advanced Bowel Preparation integrates a smartphone-based educational app (Tian Tian Yi Chi go, developed by UIC Corp.) with a Prepackaged Low-Residue Diet (PLD).
干预措施: Prepackaged Low-Residue Diet (Dietary Supplement)
结局指标
主要结局
Percentage of subjects that achieve adequate cleansing
时间窗: Day1
The percentage of subjects that achieve adequate cleansing (score ≧ 6) in the Boston Bowel Preparation Scale (BBPS)
次要结局
- The percentage of subjects that achieve excellent cleansing(Day1)
- Mean score in different colon segments(Day1)
- Adenoma Detection Rate (ADR)(Day14)
- Sessile Serrated Polyp (SSP) Detection Rate(Day14)
- Patient Satisfaction(Day1)
研究者
Chen-Ming Hsu
Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital