Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility

NCT ID: NCT03286764

Last Updated: 2020-04-03

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-10

Brief Summary

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The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.

Detailed Description

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Conditions

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Enhancement of the ADR During Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Distilled water spray as a placebo during Colonoscopy

Group Type PLACEBO_COMPARATOR

Distilled water

Intervention Type OTHER

Distilled water spray as a placebo during Colonoscopy

Peppermint Oil

Peppermint Oil spray during Colonoscopy

Group Type EXPERIMENTAL

Peppermint Oil

Intervention Type OTHER

Interventions

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Peppermint Oil

Intervention Type OTHER

Distilled water

Distilled water spray as a placebo during Colonoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Screening colonoscopy
* Age 50 years and older
* Able to give consent

Exclusion Criteria

* No consent obtained or adult lacking capacity to consent
* Do not reach cecum on colonoscopy
* Renal impairment (defined as CrCl \<30 ml/min)
* Allergy to study peppermint oil solution
* History of colon resection
* Inflammatory bowel disease
* Known colorectal neoplasia
* Non-correctable coagulopathy
* Pregnancy or lactating
* Prisoners
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kevin C. Ruff, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin C Ruff

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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14-006242

Identifier Type: -

Identifier Source: org_study_id

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