NCT07290816尚未招募不适用
Effect of Non-invasive Neuromodulation on the Quality of Bowel Cleansing: a Randomized, Controlled, Double-blind Clinical Study
Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2025年12月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Bowel Preparedness Score
研究概览
简要总结
To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 78 years of age, male or female;
- •Intended to undergo diagnostic, screening, or surveillance colonoscopy;
- •Signed written informed consent.
排除标准
- •Severe cardiac, cerebral, pulmonary, or renal complications or a history of acute cardiac infarction within six months;
- •High risk factors for bowel preparation such as history of colon surgery, BMI ≥ 28, inflammatory bowel disease, constipation (less than 3 bowel movements in the last week, and with straining to defecate, with hard stools and small amount of stools) or bowel obstruction;
- •High suspicion of colorectal cancer by auxiliary examination or early warning signs and symptoms of colorectal cancer: blood in stool, black stool, unexplained anemia, significant weight loss, abdominal mass and positive rectal fingerprinting;
- •The presence of surgical incisions or scars in the area where the electrostimulation treatment tablets are pasted, or near the ST36 acupoints on both legs;
- •Are participating in other clinical observation trials or have participated in other clinical trials within 30 days.
结局指标
主要结局
Bowel Preparedness Score
时间窗: Day 2
Using the Boston Bowel Preparation Scale(BBPS)
次要结局
- Polyp detection rate(Day 2)
- Adenoma detection rate(Day 2)
- Adverse reactions(Baseline and Day 2)
- Complete Blood Count(Baseline and Day 2)
- C-Reactive Protein(Baseline and Day 2)
- Inflammatory Cytokines(TNF-α，IL-6，IL-10……)(Baseline and Day 2)
- Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……)(Baseline and Day 2)
研究者
研究点 (1)
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