Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

April 3, 2023 updated by: Uayporn Kaosombatwattana, Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

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

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of internal medicine siriraj hospital, Mahidol university

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Mahidol University

Collaborators

The Royal College of Physicians of Thailand

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 (Actual)

March 1, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 098/2021

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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