Colonic Polyp
Conditions
Keywords
Peppermint oil, Adenoma detection rate, Colonic peristalsis
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.
Interventions
DRUGIntraluminal peppermint oil
Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal
DRUGPlacebo
Intraluminal flushing of placebo solution through the scope during scope withdrawal
Sponsors
The Royal College of Physicians of Thailand
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate(ADR) | During colonoscopy | Number of adenoma per total participants who were colonoscopy in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Adeverse events | 24 hours after colonoscopy | Total number of adverse events in both groups |
Countries
Thailand
Outcome results
None listed