Assessment of peppermint extract effect on colonoscopy quality in patients referring to Urmia Imam Khomeini hospital

Determining peppermint extract effect on colonoscopy quality in patients referring to Urmia Imam Khomeini hospital

This study will be performed as a double-blind clinical trial with parallel groups (phase 3) on 128 patients. Patients will be divided into two groups of intervention and placebo using a simple random method and a random number table.

In this study, 128 patients referred to the colonoscopy ward of Urmia Imam Khomeini hospital will be included in the study. Patients will be randomly divided into an intervention group (50 cc peppermint extract) and placebo group (50 cc drinking water) using a random number table. Peppermint and placebo extract will be applied to various parts of the large intestine during colonoscopy.

Patients aged between18 and 65 who are suspected of having colon polyps, colon disease, or bleeding of unknown origin will undergo colonoscopy. Inclusion criteria: not consuming antispasmodics, suspicion of colon polyps, colon diseases, bleeding of unknown origin. Exclusion criteria: having irritable bowel syndrome, lack of mental health and full consciousness, use of anti-anxiety and analgesic drugs, having a history of allergies to any type of drugs

In the intervention group, 50 cc of peppermint extract and in the control group, 50 cc of drinking water will be injected into the colon during colonoscopy through the working channel in various areas of the large intestine.

Total procedure time, pain, time to reach the cecum

Randomization will be performed in a simple randomization method by using a table of random numbers. Each patient will first be assigned a three-digit code. The first patient will have code 001 and the last patient will have code 128. A number will then be selected randomly. The first three digits will be examined. It will be continued from top to bottom in the table to complete the sample size. If the number is less than or equal to 128, that number will be selected. The duplicate number will be ignored and another number from the table will be checked. Numbers between 001 and 064 will be assigned to the intervention group and numbers between 065 and 128 will be assigned to the placebo group.

The study will be double-blind. The patient and the endoscopist will be blind that which groups each patient belongs to. Peppermint extract and placebo will be the same in volume and color. Due to the smell of peppermint extract, in order the endoscopist not be noticed the placebo and the peppermint, before starting the endoscopy, some peppermint extract will be sprayed into the endoscopy room to smell only peppermint extract.