Effect of a Novel Colonoscopic Lavage Solution on Colonoscopy Quality

NCT07501975 | Not Yet Recruiting DMC

• 1 other identifier: 2026-KY-0395-001
• Study Type: interventional
• Target: 498
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0

Secondary Outcomes (3)

• Incidence of intestinal spasm

  Day 0

• Spasm inhibition rate

  Day 0

• Polyp detection rate (PDR)

  Day 0

Study Arms (2)

Irrigation solution group

EXPERIMENTAL

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.

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

placebo group

PLACEBO COMPARATOR

Irrigation was performed endoscopically using normal saline.

Diagnostic Test: Irrigation was performed endoscopically using normal saline.

Interventions

Endoscopic irrigation was performed using a novel irrigation solution DIAGNOSTIC_TEST

Endoscopic irrigation was performed using a novel irrigation solution (0.1% menthol solution combined with simethicone aqueous suspension).

Irrigation solution group

Irrigation was performed endoscopically using normal saline. DIAGNOSTIC_TEST

Irrigation was performed endoscopically using normal saline.

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Central Study Contacts

Jianning Yao

CONTACT

13733183434; rjyy@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03