L-Menthol Infusion as a Novel Technique During Colonoscopy

• Status: Terminated
• Trial end date: 2019-04-12
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this double-blinded, prospective, randomized placebo-controlled study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of peppermint oil solution vs placebo application during colonoscopy. The investigators hypothesize that ADR will be increased with the use of the peppermint oil solution and thus further reduce the risk of colon cancer by means of colonoscopy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Menthol; Peppermint oil

Criteria

Inclusion Criteria:

1. At least 50 years of age in Caucasians or 45 years of age in African-Americans.

2. Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.

3. Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.

Exclusion Criteria:

1. History of colectomy, partial or complete

2. Symptoms suggesting possible colorectal stenosis or cancer

3. Inflammatory bowel disease

4. Familial polyposis syndromes

5. History of, or current diagnosis of colorectal cancer

6. American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater

7. Non-correctable coagulopathy

8. Currently receiving anti-thrombotic therapy, with an INR > 1.5

9. Poor prep, total BBPS score < 6, or any part of the colon < 2.

10. Patients with known allergy to peppermint oil or peppermint containing products.

11. Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil, Diltiazem, Dihydropyridine, Felodipine, etc).