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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ala'a Sharara, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01541683
First received: February 21, 2012
Last updated: August 5, 2013
Last verified: August 2013

February 21, 2012
August 5, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
measurement of Palatability of the PEG-electrolyte solution [ Time Frame: 1.5 hours after drinking the solution ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01541683 on ClinicalTrials.gov Archive Site
  • volume remaining of the colon preparation solution [ Time Frame: 1.5 hours after drinking the solution ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1.5 hours after drinking the solution ] [ Designated as safety issue: Yes ]
    number of patients who experienced nausea, vomiting, bloating, abdominal cramps or headaches while drinking the solution.
Same as current
Not Provided
Not Provided
 
The Effect of Mentholyptus Drops on the Palatability of PEG-Electrolyte Solution
The Effect of Mentholyptus Drops (Halls®) on the Palatability of PEG-Electrolyte Solution (FORTRANS®) in Colonoscopy Preparation: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Colon Cancer
  • 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®)
  • Other: 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)
  • Experimental: Halls
    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®).
    Intervention: Other: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)
  • no 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)
    Intervention: Other: PEG solution (Fortrans®)
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):886-91. doi: 10.1016/j.gie.2013.05.015. Epub 2013 Jun 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Lebanon
 
NCT01541683
IM.AS1.28
Yes
Ala'a Sharara, American University of Beirut Medical Center
American University of Beirut Medical Center
Not Provided
Principal Investigator: Ala I Sharara, MD American University of Beirut Medical Center
American University of Beirut Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP