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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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Die klinische Studie NCT07501962 ist eine interventionsstudie zur Untersuchung von Koloskopie und hat den Status noch nicht rekrutierend. Der Start ist für 1. April 2026 geplant, bis 440 Teilnehmer aufgenommen werden. Durchgeführt von The First Affiliated Hospital of Zhengzhou University wird der Abschluss für 31. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. März 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel

Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study

Erkrankungen
Koloskopie
Weitere Studien-IDs
  • 2026-KY-0394-001
NCT-Nummer
NCT07501962
Studienbeginn (tatsächlich)
2026-04-01
Zuletzt aktualisiert
2026-03-30
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
440
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Primäres Ziel
Diagnostisch
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellMenthol 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.
Placebo-Vergleichspräparatplacebo 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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  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.

  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.
The First Affiliated Hospital of Zhengzhou University logoThe First Affiliated Hospital of Zhengzhou University
Verantwortliche Partei
Jianning Yao, Hauptprüfer, Chief Physician, The First Affiliated Hospital of Zhengzhou University
Zentrale Studienkontakte
Kontakt: Jianning Yao, 13733183434, [email protected]
Keine Standortdaten vorhanden