Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Mahidol University

Status: Completed

Conditions: Colonic Polyp

Treatments: Drug: Intraluminal peppermint oil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05559814

Si 098/2021

Details and patient eligibility

About

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.

Enrollment: 404 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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404 participants in 2 patient groups, including a placebo group

Peppermint oil

Experimental group

Description:

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

Treatment:

Drug: Intraluminal peppermint oil

Placebo

Placebo Comparator group

Description:

Placebo solution 50ml(Simethicone plus tween)

Treatment:

Drug: Placebo