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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541683
• Other study ID #: IM.AS1.28
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: August 5, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Other:
• PEG 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®)
• PEG 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)

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes