The Effect of Mentholyptus Drops on the Palatability of PEG-Electrolyte Solution

Study Overview
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Brief Summary
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The investigators aim is to study the efficacy of mentholyptus drops in improving the palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study is a randomized controlled trial which will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. Patients assigned to the intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution unlike the control arm patients who will only receive the PEG solution. All patients will then be evaluated for the tolerability of the preparation while taking into account the palatability of the solution as main outcome and the remaining volume of the PEG solution and side effects as secondary outcomes.

Official Title
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The Effect of Mentholyptus Drops (Halls®) on the Palatability of PEG-Electrolyte Solution (FORTRANS®) in Colonoscopy Preparation: A Randomized Controlled Trial

Conditions
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Colon Cancer

Intervention / Treatment
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* Other: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)
* Other: PEG solution (Fortrans®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective colonoscopy consent to the study Exclusion Criteria: pregnant or lactating women age less than 18 years significant gastroparesis gastric outlet obstruction ileus known or suspected bowel obstruction or perforation phenylketonuria glucose-6-phosphate dehydrogenase deficiency severe chronic renal failure (creatinine clearance <30 mL/minute) severe congestive heart failure (NYHA class III or IV) dehydration severe acute inflammatory disease compromised swallowing reflex or mental status uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg) toxic colitis or megacolon previous colonoscopy within the last 5 years active Inflammatory bowel disease previous colectomy or partial colectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Halls<br>every patient will drink 4 Liters of PEG solution (FORTRANS®) split into 2 days with sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy with Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure with Halls®). | Other: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)<br>* Patients will be instructed to drink 4 Liters of PEG solution (FORTRANS®) split into 2 days while sucking on sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy while continuously sucking on Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure while continuously sucking on Halls®)<br>|
| Other: no Halls<br>Every patient will drink 4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure) | Other: PEG solution (Fortrans®)<br>* 4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of Palatability of the PEG-electrolyte solution | patients will be asked to assess the palatability of the colon preparation solution (Fortrans®) by giving it a score on a scale from 1 to 5 with 1 being disgusting and 5 being tasty after drinking the whole solution and immediately prior to the colonoscopy | 1.5 hours after drinking the solution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume remaining of the colon preparation solution | Patients will be asked to bring with them to the endoscopy suit the volume remaining, if any, of the colon preparation solution that they were not able to drink. The volume remaining will be measured by the research fellow using a graduated cylinder. | 1.5 hours after drinking the solution | 
| Side effects | number of patients who experienced nausea, vomiting, bloating, abdominal cramps or headaches while drinking the solution. | 1.5 hours after drinking the solution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-electrolyte solution, bowel cleansing, Mentholyptus drops, Palatability