Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

NCT05559814 | Completed

• 1 other identifier: Si 098/2021
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp

Keywords

Peppermint oil, Adenoma detection rate, Colonic peristalsis

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate(ADR)

  Number of adenoma per total participants who were colonoscopy in both groups

  During colonoscopy

Secondary Outcomes (5)

• Adenoma per posititive participants(APP)

  During colonoscopy

• Colonic peristalsis grading

  During colonoscopy

• Time of polyps resection

  During colonoscopy

• Intravenous anti-spasmodic agents

  During colonoscopy

• Adeverse events

  24 hours after colonoscopy

Study Arms (2)

Peppermint oil

EXPERIMENTAL

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

Drug: Intraluminal peppermint oil

Placebo

PLACEBO COMPARATOR

Placebo solution 50ml(Simethicone plus tween)

Drug: Placebo

Interventions

Intraluminal peppermint oil DRUG

Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal

Peppermint oil

Placebo DRUG

Intraluminal flushing of placebo solution through the scope during scope withdrawal

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants with age \> 18 years who attended for colorectal cancer screening colonoscopy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• The Royal College of Physicians of Thailand: collaborator

Study Sites (1)

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medicine, Siriraj Hospital, Mahidol university

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: March 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

TH (1)