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

NCT ID: NCT01541683

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-07-31

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.

Conditions

Colon Cancer

Keywords

PEG-electrolyte solution; bowel cleansing; Mentholyptus drops; Palatability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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®).

Group Type: EXPERIMENTAL

PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)

Intervention Type: 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®)

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)

Group Type: OTHER

PEG solution (Fortrans®)

Intervention Type: 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)

Interventions

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®)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ala'a Sharara

Head and Professor, Division of Gastroenterology and Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ala I Sharara, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical Center

Beirut, Beyrouth, Lebanon

Countries

Lebanon

References

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.

Reference Type: DERIVED

PMID: 23769143 (View on PubMed)

Other Identifiers

IM.AS1.28

Identifier Type: -

Identifier Source: org_study_id