NCT07501975

Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality

Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality: A Randomized Controlled Trial Evaluating Efficacy and Safety

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 498 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Endoscopic irrigation was performed using a novel irrigation solution	Endoscopic irrigation was performed using a novel irrigation solution (0.1% menthol solution combined with simethicone aqueous suspension).
DIAGNOSTIC_TEST	Irrigation was performed endoscopically using normal saline.	Irrigation was performed endoscopically using normal saline.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30