Colon Cancer
Conditions
Keywords
PEG-electrolyte solution, bowel cleansing, Mentholyptus drops, Palatability
Brief summary
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.
Interventions
OTHERPEG solution (Fortrans®) and Mentholyptus Drops (Halls®)
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®)
OTHERPEG solution (Fortrans®)
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)
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of Palatability of the PEG-electrolyte solution | 1.5 hours after drinking the 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| volume remaining of the colon preparation solution | 1.5 hours after drinking the 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. |
| Side effects | 1.5 hours after drinking the solution | number of patients who experienced nausea, vomiting, bloating, abdominal cramps or headaches while drinking the solution. |
Countries
Lebanon
Outcome results
None listed