Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT05559814

Collaborator

The Royal College of Physicians of Thailand (Other)

404

Enrollment

Location

Arms

Actual Duration (Months)

25.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp	Drug: Intraluminal peppermint oil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

404 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

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 to reduce colonic peristalsis.
Placebo Comparator: Placebo Placebo solution 50ml(Simethicone plus tween)	Drug: Intraluminal peppermint oil Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal to reduce colonic peristalsis.

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 to reduce colonic peristalsis.

Placebo Comparator: Placebo

Placebo solution 50ml(Simethicone plus tween)

Drug: Intraluminal peppermint oil

Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal to reduce colonic peristalsis.

Outcome Measures

Primary Outcome Measures

Adenoma detection rate(ADR) [During colonoscopy]
Number of adenoma per total participants who were colonoscopy in both groups

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of internal medicine siriraj hospital, Mahidol university	Bangkok Noi	Bangkok	Thailand	10700

Sponsors and Collaborators

Mahidol University
The Royal College of Physicians of Thailand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uayporn Kaosombatwattana, Department of Medicine, Siriraj Hospital, Mahidol university, Mahidol University

ClinicalTrials.gov Identifier:

NCT05559814

Other Study ID Numbers:

Si 098/2021

First Posted:

Sep 29, 2022

Last Update Posted:

Oct 7, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Uayporn Kaosombatwattana, Department of Medicine, Siriraj Hospital, Mahidol university, Mahidol University

Peppermint oil, Adenoma detection rate, Colonic peristalsis

Additional relevant MeSH terms:

Adenoma

Colonic Polyps

Peppermint oil

Study Results

No Results Posted as of Oct 7, 2022