Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Study Overview
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Brief Summary
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This is a prospective randomized placebo-controlled trial to evaluate the efficacy of peppermint oil spraying into the colonic lumen through the scope channel during screening colonoscopy. The primary outcome is to compare the colonic peristalsis between peppermint oil and placebo. The secondary outcomes compare the procedural time, polyp detection rate, adenoma detection rate, and adverse events.

Official Title
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Intraluminal Peppermint Oil Can Increase Adenoma Detection Rate in Colon Cancer Screening Colonoscopy: A Double- Blinded Randomized Controlled Trial

Conditions
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Colonic Polyp

Intervention / Treatment
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* Drug: Intraluminal peppermint oil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Participants with age > 18 years who attended for colorectal cancer screening colonoscopy. Exclusion Criteria: Participants who had been colectomy Participants who diagnosed of inflammatory bowel disease or polyposis syndrome. Participants who had been took anti-spasmosic drugs prior to colonoscopy within 24 hours (Anticholibergic/Antimuscarinic : Hyoscine(Buscopan®), Dicyclomine(Berclomine®) or Smooth muscle relaxant : Mebeverine(Duspatin®,Colofac®), Pinaverium bromide(Dicetel®), Alverine(Meteospasmyl®), Peppermint oil(Colpermin®)) Participants with Prothrombin time > 3 second ULN, INR > 1.5 or Platelet < 50,000. Pregnancy or breast feeding Participants who cannot consent. Participants who had history of peppermint oil allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peppermint oil<br>1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween) | Drug: Intraluminal peppermint oil<br>* Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal<br>|
| Placebo Comparator: Placebo<br>Placebo solution 50ml(Simethicone plus tween) | Drug: Placebo<br>* Intraluminal flushing of placebo solution through the scope during scope withdrawal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate(ADR) | Number of adenoma per total participants who were colonoscopy in both groups | During colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma per posititive participants(APP) | Number of aenama in patients who had found at least one adenoma in both groups | During colonoscopy | 
| Colonic peristalsis grading | Percentage of colonic peristalsis grade 0 and 1 in peppermint oil group in both groups | During colonoscopy | 
| Time of polyps resection | Time of polypectomy per polyp in both groups | During colonoscopy | 
| Intravenous anti-spasmodic agents | Percentage of intravenous anti-spasmodic agents in both groups | During colonoscopy | 
| Adeverse events | Total number of adverse events in both groups | 24 hours after colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peppermint oil, Adenoma detection rate, Colonic peristalsis