Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 440
- 主要终点
- Incidence of intestinal spasm
研究概览
简要总结
In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol relaxes intestinal smooth muscle and alleviates spasm symptoms by antagonizing L-type calcium channels on the smooth muscle cell membrane, thereby reducing calcium influx. Furthermore, it exhibits local analgesic effects and can attenuate visceral hypersensitivity. Some studies suggest that oral or topical administration of peppermint oil preparations may improve intestinal spasm during colonoscopy, highlighting its potential utility in digestive endoscopy procedures. Nevertheless, current research on the spasmolytic efficacy and safety of menthol solution when administered via endoscopic irrigation during colonoscopy remains limited, and high-quality clinical trials are urgently needed for validation. This study aims to investigate the effectiveness and safety of menthol solution in relieving intestinal spasm, thereby providing scientific evidence for optimizing colonoscopy procedures.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Age between 18 and 75 years, regardless of gender;
- •Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
- •Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
- •Voluntarily signed informed consent and able to cooperate with completing study-related assessments.
排除标准
- •Allergy to menthol, cyclodextrin, or related substances;
- •History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
- •Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
- •Pregnant or lactating women;
- •Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
- •Psychiatric disorders or cognitive impairment that prevent cooperation with the study;
- •History of contraindications to colonoscopy or serious adverse reactions during previous procedures.
结局指标
主要结局
Incidence of intestinal spasm
时间窗: Day 0
Intestinal spasm score: Score 1 (Excellent): No spasm; the lumen opening is greater than or equal to two-thirds of the maximum diameter. Score 2 (Moderate): Moderate spasm; the lumen opening is less than two-thirds of the maximum diameter. Score 3 (Poor): Severe spasm; the oral-side lumen cannot be visualized. The maximum diameter is defined as the diameter of the intestinal lumen when fully distended. Spasm incidence: The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group.
adenoma detection rate (ADR)
时间窗: Day 0
ADR = (Number of patients with at least one adenomatous polyp detected / Total number of patients in the group) × 100%. Pathological diagnosis was used as the gold standard.
次要结局
- Spasm inhibition rate(Day 0)
- Polyp detection rate (PDR)(Day 0)
研究者
Jianning Yao
Chief Physician
The First Affiliated Hospital of Zhengzhou University