In recent years, with the continuous advancement of digestive endoscopy techniques, how to improve the adenoma detection rate (ADR) by optimizing endoscopic procedural details has become a research hotspot. Colonic spasm can lead to narrowing of the intestinal lumen, deepening of mucosal folds, and limited field of view, thereby affecting lesion exposure and reducing examination quality. Although traditional intravenous antispasmodic drugs (such as scopolamine) can alleviate intestinal spasms, they may cause side effects such as increased heart rate, blood pressure fluctuations, and other systemic adverse reactions. In contrast, menthol is a natural monoterpene compound derived from peppermint oil. It can inhibit L-type calcium channels on the cell membrane of smooth muscle through local application, thereby reducing intracellular calcium concentration and inducing smooth muscle relaxation. This helps to relieve intestinal spasms and patient discomfort during colonoscopy. On the other hand, simethicone, a commonly used defoaming agent, can reduce surface tension, eliminate foam, and improve mucosal visualization. Theoretically, combining antispasmodic menthol with defoaming simethicone may further optimize the visual field during colonoscopy and increase the ADR through a synergistic "antispasmodic + defoaming" mechanism. Therefore, this study plans to conduct a prospective randomized controlled trial to evaluate the antispasmodic effect, safety, and impact on the ADR of a novel irrigation solution (0.1% menthol combined with simethicone suspension) in colonoscopy, providing evidence-based medical support for optimizing endoscopic procedures.
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.
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;
Parallel
Endoscopic irrigation was performed using a novel irrigation solution
Diagnostic testEndoscopic irrigation was performed using a novel irrigation solution (0.1% menthol solution combined with simethicone aqueous suspension).
Irrigation was performed endoscopically using normal saline.
Diagnostic testIrrigation was performed endoscopically using normal saline.
Adenoma detection rate (ADR).
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.
Incidence of intestinal spasm
The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group. Intestinal spasm scoring criteria: 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 inhibition rate
The percentage of patients whose lumen opening exceeded two-thirds of the maximum diameter within 30 seconds after water injection irrigation, relative to the total number of patients in the group.
Polyp detection rate (PDR)
PDR = (number of patients with at least one polyp detected / total number of patients in the group) × 100%.
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