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El ensayo clínico NCT07501962 para Colonoscopia está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate 440
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El ensayo clínico NCT07501962 es un estudio intervencionista para Colonoscopia. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de abril de 2026 hasta completar 440 participantes. Dirigido por The First Affiliated Hospital of Zhengzhou University, se espera que finalice el 31 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 30 de marzo de 2026.
Resumen
In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol rel...Mostrar más
Título oficial
Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study
Condiciones médicas
ColonoscopiaOtros ID del estudio
- 2026-KY-0394-001
Número del NCT
Inicio del estudio (real)
2026-04-01
Última actualización
2026-03-30
Fecha de finalización (estimada)
2026-12-31
Inscripción (prevista)
440
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Objetivo principal
Diagnóstico
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalMenthol group Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. Preparation method: Normal saline was used 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 prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. | Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. Preparation method: Normal saline was used 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 prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. |
Comparador placeboplacebo group Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. | Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Incidence of intestinal spasm | Intestinal spasm score:
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 incidence: The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group. | Day 0 |
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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. | Day 0 |
Polyp detection rate (PDR) | PDR = (Number of patients with at least one polyp detected / Total number of patients in the group) × 100%. | Day 0 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 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;
- 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.
The First Affiliated Hospital of Zhengzhou UniversityParte responsable del estudio
Jianning Yao, Investigador principal, Chief Physician, The First Affiliated Hospital of Zhengzhou University
Contactos centrales del estudio
Contacto: Jianning Yao, 13733183434, [email protected]
Sitio no especificado.