Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01788709 |
| Other study ID # |
IM.AS1.32 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
February 8, 2013 |
| Last updated |
June 23, 2014 |
| Start date |
January 2013 |
| Est. completion date |
June 2014 |
Study information
| Verified date |
January 2013 |
| Source |
American University of Beirut Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Lebanon: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial 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.
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
