Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality

Zhengzhou University

Status: Not yet enrolling

Conditions: Colonoscopy

Treatments: Diagnostic Test: Irrigation was performed endoscopically using normal saline.; Diagnostic Test: Endoscopic irrigation was performed using a novel irrigation solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07501975

2026-KY-0395-001

Details and patient eligibility

About

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.

Enrollment: 498 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 18 and 75 years, regardless of gender;
2. Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
3. Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
4. Voluntarily signed informed consent and able to cooperate with completing study-related assessments.

Exclusion criteria

1. Allergy to menthol, cyclodextrin, or related substances;
2. History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
3. Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
4. Pregnant or lactating women;
5. Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
6. Psychiatric disorders or cognitive impairment that prevent cooperation with the study;
7. History of contraindications to colonoscopy or serious adverse reactions during previous procedures.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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498 participants in 2 patient groups, including a placebo group

Irrigation solution group

Experimental group

Description:

Endoscopic irrigation was performed using a novel irrigation solution (0.1% menthol solution combined with simethicone aqueous suspension). Preparation method: The solution was prepared using normal saline as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to obtain a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to prepare the aqueous suspension.

Treatment:

Diagnostic Test: Endoscopic irrigation was performed using a novel irrigation solution

placebo group

Placebo Comparator group

Description:

Irrigation was performed endoscopically using normal saline.

Treatment:

Diagnostic Test: Irrigation was performed endoscopically using normal saline.