Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility

April 2, 2020 updated by: Kevin C. Ruff, M.D., Mayo Clinic
The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Distilled water spray as a placebo during Colonoscopy
Other: Distilled water
Distilled water spray as a placebo during Colonoscopy
EXPERIMENTAL: Peppermint Oil
Peppermint Oil spray during Colonoscopy
Other: Peppermint Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of Adenoma Detection Rate during Colonoscopy Procedure
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kevin C Ruff, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

September 10, 2019

Study Completion (ACTUAL)

September 10, 2019

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (ACTUAL)

September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-006242

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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