An interventional study of PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) and PEG solution (Fortrans®) in Colon Cancer, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-07.
Sponsored by American University of Beirut Medical Center · Not applicable and Interventional
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 99 is close to the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
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®)
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®)
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®)
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)
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
Time frame: 1.5 hours after drinking the solution
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.
Time frame: 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.
Time frame: 1.5 hours after drinking the solution
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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American University of Beirut Medical Center