Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-06-30

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.

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Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Peppermint oil

1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween)

Group Type EXPERIMENTAL

Intraluminal peppermint oil

Intervention Type DRUG

Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal

Placebo

Placebo solution 50ml(Simethicone plus tween)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intraluminal flushing of placebo solution through the scope during scope withdrawal

Interventions

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Intraluminal peppermint oil

Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal

Intervention Type DRUG

Placebo

Intraluminal flushing of placebo solution through the scope during scope withdrawal

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes