L-Menthol Infusion as a Novel Technique During Colonoscopy

Adult subjects who are undergoing colonoscopy for primary colorectal cancer screening or
surveillance. The study will be carried out as a prospective, double-blinded, fully-masked
randomized controlled trial. Prior to the trial entry, the participant's labs and medical
record will be reviewed in the electronic records system. If the subject meets
inclusion/exclusion criteria, he or she will be consented at bedside prior undergoing their
scheduled procedure and receive standard care as otherwise. Experimental and placebo solution
ingredients will be serially numbered and randomized in a 1:1 ratio using a variable block
strategy and provided by the institutional investigational pharmacy. Research staff will draw
up experimental or placebo solution in 4 syringes with a total of 20mL in each solution.

The solutions are identical in appearance and endoscopic delivery. To prevent olfactory
detection of the peppermint oil solution an essential oil diffuser will be used in all
endoscopy rooms using the same oil as in the experimental solution. Endoscopists will be
instructed to deliver the contents of one syringe sprayed via the endoscope in the cecum and
one in the sigmoid colon. The contents of the other two syringes are to be delivered at the
discretion of the endoscopist. After the procedure, endoscopists and study participants will
be surveyed to determine if blinding was effective and to assess patient comfort levels,
respectively. The primary and secondary end points will be determined on an intention to
treat basis.

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).