Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559814
• Other study ID #: Si 098/2021
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Drug:
• Intraluminal peppermint oil
Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal
• Placebo
Intraluminal flushing of placebo solution through the scope during scope withdrawal

Locations

Country	Name	City	State
Thailand	Faculty of internal medicine siriraj hospital, Mahidol university	Bangkok Noi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	The Royal College of Physicians of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

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