Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Not Applicable

Completed

• Conditions: Colonic Polyp
• Interventions: Drug: Intraluminal peppermint oil; Drug: Placebo

• Registration Number: NCT05559814
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peppermint oil	Intraluminal peppermint oil	1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween)
Placebo	Placebo	Placebo solution 50ml(Simethicone plus tween)

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate(ADR)	During colonoscopy	Number of adenoma per total participants who were colonoscopy in both groups

Secondary Outcome Measures

Name	Time	Method
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
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
Adeverse events	24 hours after colonoscopy	Total number of adverse events in both groups

Trial Locations

Locations (1)

Faculty of internal medicine siriraj hospital, Mahidol university; 🇹🇭 Bangkok Noi, Bangkok, Thailand