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Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality

NCT07501975 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2026-03-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501975 on ClinicalTrials.gov