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Completed

NCT Number: NCT05559814

Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

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.

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraluminal peppermint oil

Drug

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

Placebo

Drug

Intraluminal flushing of placebo solution through the scope during scope withdrawal

Primary outcomes

  1. Adenoma detection rate(ADR)

    Time frame: During colonoscopy

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

Secondary outcomes

  1. Adenoma per posititive participants(APP)

    Time frame: During colonoscopy

    Number of aenama in patients who had found at least one adenoma in both groups

  2. Colonic peristalsis grading

    Time frame: During colonoscopy

    Percentage of colonic peristalsis grade 0 and 1 in peppermint oil group in both groups

  3. Time of polyps resection

    Time frame: During colonoscopy

    Time of polypectomy per polyp in both groups

  4. Intravenous anti-spasmodic agents

    Time frame: During colonoscopy

    Percentage of intravenous anti-spasmodic agents in both groups

  5. Adeverse events

    Time frame: 24 hours after colonoscopy

    Total number of adverse events in both groups

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • The Royal College of Physicians of Thailand

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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