PEG-Electrolyte Solution (FORTRANS®) With Mentholyptus Drops (Halls®) Versus Reduced Volume Ascorbic Acid Supplemented PEG-Electrolyte (MoviPrep®) in Colonoscopy Preparation
Condition: Bowel Cleansing in Preparation for Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately
      prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient
      discomfort, and eventually increase complication rate. Therefore an excellent colon cleansing
      is of extreme importance to the endoscopist and the patient.

      Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability
      and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte
      (MoviPrep®) in bowel cleansing for colonoscopy.
    

Detailed description: 
      Abstract:

      Colorectal cancer is amongst the leading cancers worldwide. Treatment is greatly dependent on
      the stage of illness, with more favorable outcomes associated with early cancers. For this
      reason, screening colonoscopies have been increasing, as are efforts to improve the quality
      of bowel preparations. The colonoscopy accuracy and safety depend on the quality of colon
      cleansing. An inadequately prepped bowel will increase the risk of missing a lesion, prolong
      procedure, increase patient discomfort, and eventually increase complication rate. Hence, an
      Ideal bowel cleansing solution would quickly and reliably clean the colon while having a good
      tolerability and palatability to the patient. Current colonoscopy preparation regimens
      require the use of large volume of iso-osmotic PEG-electrolyte solution for adequate
      cleansing and are often poorly tolerated by patients. We have shown previously that
      mentholyptus drops significantly improved the palatability of PEG-electrolyte (Fortrans®)
      solution and the quality of preparation (1). We aim at this study to compare the efficacy of
      the above-mentioned prep technique and the reduced volume ascorbic acid-supplemented
      PEG-electrolyte (MoviPrep®). This is a randomized controlled trial that 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.
      100 Patients will be asked to have candy (Halls®) during the whole 2 hours period while
      drinking the PEG solution (Fortrans®). Another 100 patients will be asked to take reduced
      volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®). All patients will then be
      interviewed by the research coordinator to evaluate 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. Based on the results of a pilot
      study, our sample size calculation showed that 100 patients per arm will be enough to attain
      significance. As for the statistical analysis, SPSS version 20.0 will be used for data entry
      and analysis.

      I- Aim:

      To compare the efficacy of split PEG-electrolyte (Fortrans®) with mentholyptus (Halls®) drops
      and the reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®) in improving
      the palatability of solution used in bowel cleansing for colonoscopy.

      II- Background:

      The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately
      prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient
      discomfort, and eventually increase complication rate. Therefore an excellent colon cleansing
      is of extreme importance to the endoscopist and the patient. Hence, An Ideal bowel cleansing
      solution would quickly and reliably clean the colon while having a good tolerability and
      palatability to the patient. Poor tolerability by the patient would increase the risk of not
      finishing the whole solution and hence the risk of having a poor colon cleansing. Many types
      of bowel cleansing solutions are currently available in the market. Current colonoscopy
      preparation regimens require the use of large volume of iso-osmotic PEG-electrolyte solution
      for adequate cleansing and are often poorly tolerated by patients. Therefore, improving the
      tolerability of the solution by patients is of critical importance. The main side effects of
      bowel cleansing solution are nausea, vomiting, bloating, and cramps. To decrease their
      incidence and therefore to improve tolerability, one could either decrease the volume of the
      solution or improve its palatability. Many studies have tried to decrease the volume of the
      solution below the standard 4 liters. These studies have largely shown that smaller volume
      preps are inferior to standard preps. In addition, few studies have shown that improving
      palatability by adding a flavor improved patients' acceptance of the solution (2-6).
      MoviPrep® is the only liquid PEG bowel cleansing agent that incorporates ascorbic acid in its
      formulation, thus contributing to its lemon taste and consequently better patient
      tolerability. We have proved earlier this year through a randomized trial a high palatability
      of and hence a better quality of preparation (90% Good/Excellent) using the PEG-electrolyte
      Fortrans® with sugar-free mentholyptus drops (Halls®) (6).

      We aim at comparing the colonoscopy preparation quality and the palatability of our technique
      and that of the MoviPrep® through a single blinded randomized trial.

      III- Hypothesis:

      Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability
      and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte
      (MoviPrep®) in bowel cleansing for colonoscopy.

      IV- Setting:

      Single university based center (American University of Beirut Medical Center)

      V- Study Design:

      Prospective randomized single-blinded study

      VI- Methods:

        1. Study population:

             1. Inclusion criteria:

                ● Elective colonoscopy

                  -  Consent to the study

             2. 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 (New York Heart Association [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

                These exclusion criteria are consistent with contraindications of currently
                approved bowel preparations; therefore, the results of this study may be
                generalized to the entire target population of patients undergoing colonoscopy,
                including the elderly.

        2. Randomization:

           Patients will be enrolled by the principal investigator or study coordinator (MD) after
           assessing for inclusion and exclusion criteria. Patients will then be randomized into
           one of the two study arms using a pre-set randomization list where patients with an odd
           number as the last digit of their medical record will be assigned to the control arm and
           patients with an even number will be assigned to the intervention arm.

        3. Study arms:

           ● First arm: 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 at least 1.5 hours before the procedure
           with Halls®).

           ● Second arm: 2 Liters of reduced volume ascorbic acid-supplemented PEG-electrolyte
           (MoviPrep®) + 1 Liter of clear fluids of the patients' choice split into 2 days (1 L of
           MoviPrep® on the evening of the day prior to the colonoscopy + 500 mL of clear fluids of
           the patients choice, and another 1 L of MoviPrep® + 500 mL of clear fluids on the day of
           the colonoscopy to be completed at least 1 hour before the procedure.)

        4. Instructions to patients:

           Patients in both arms will be instructed on how they should take the colonoscopy
           preparation solution, emphasizing the importance of complete intake of the solution in
           order to ensure a safe and effective procedure. In case of noncompliance, the remainder
           of the PEG solution shall be brought in by the patient for assessment. They will also be
           instructed to have a regular breakfast and lunch meals on the day prior to the
           colonoscopy, a full fluid dinner, and to stay NPO except for the colon prep after
           midnight till the time of colonoscopy.

        5. Assessment of tolerability:

      Immediately prior to the colonoscopy, patients from both study arms will be interviewed by
      the research coordinator to evaluate tolerability of the preparation.

      Patients will be assessed for:

        -  Primary outcome:

        -  Quality of preparation: score from 1 to 4

             1. 2 3 4 Poor Fair Good Excellent

        -  Secondary outcome:

        -  Estimated volume remaining of the original PEG solution

        -  Palatability: score 1 to 5

             1. 2 3 4 5 Disgusting Moderately poor taste Slightly poor taste Acceptable Tasty

      In addition to the following adverse events:

        -  Nausea

        -  Vomiting

        -  Bloating

        -  Cramps

        -  Headache

        -  General acceptance of the solution

        -  Willingness to take the preparation again in the future if necessary

      VII- Sample size calculation and data analysis:

      Sample size calculation was conducted based on our previously conducted study that showed a
      90% good/excellent prep with Fortrans® + Halls® and the reported results on colonoscopy
      preparations using the reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®)
      that range between 65-85% good/excellent (average: 75%) (1)(7-10). Therefore, based on these
      results and using an α of 0.05 and a power of 0.80, the sample size required to show
      significance was calculated to be 97 patients per arm. Hence, it was decided to recruit 100
      patients per arm taking into account possible withdrawals.

      For the statistical analysis, SPSS version 20.0 will be used for data entry and analysis.

      The primary end point is the quality of preparation assessed by the endoscopist (who will be
      blind to the preparation technique). Secondary end points will be: palatability, residual
      volume, patient assessment of the quality of preparation, willingness to retake the
      preparation solution again if needed.

      VIII- Study Interval:

      1 year starting from the enrollment of the first patient
    

Intervention name(s): preparation cleaning solution
Intervention type(s): Other
Other intervention name(s): Fortrans (split dose) + Mentholyptus drops; MoviPrep (split dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: colonoscopy; preparation