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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Halls | Experimental | 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®). |
|
| no Halls | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) | Other | 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®) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ala I Sharara, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Beirut | Beirut | 1107 2020 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23769143 | Derived | Sharara AI, El-Halabi MM, Abou Fadel CG, Sarkis FS. Sugar-free menthol candy drops improve the palatability and bowel cleansing effect of polyethylene glycol electrolyte solution. Gastrointest Endosc. 2013 Dec;78(6):886-891. doi: 10.1016/j.gie.2013.05.015. Epub 2013 Jun 13. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| PEG solution (Fortrans®) | Other | 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) |
|
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |