Colon Adenoma Clinical Trial
Official title:
Comparison of a Split Dose Bowel Preparation With 2-L Polyethylene Glycol Plus Ascorbic Acid and 1-L Polyethylene Glycol Plus Ascorbic Acid and Bisacodyl Prior to Colonoscopy
Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg) formulation to determine the quality of bowel cleansing and patient tolerability.
- Study design A single center, randomized, comparative observer-blinded study was performed
from May 2015 to September 2015 at the Department of Gastroenterology and Digestive
Endoscopy at Korea University Anam Hospital (Seoul, Korea).
In total, 200 outpatients received lower volume 1-L PEG with ascorbic acid plus bisacodyl
(1L-PEG/AB) or low volume 2-L PEG with ascorbic acid (2L-PEG/A) in a 1:1 ratio.
At the time of registration, subjects were randomly allocated to either group. They were
randomized by a computer-generated list and were provided with written instructions. All
patients provided written informed consent.
- Patients All patients between the ages of 20 and 75 years. Patients were excluded from
the analysis if they had known or suspected gastrointestinal obstruction, Ileus, severe
heart failure, uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic
pressure > 100 mmHg), severe constipation, clinically significant electrolyte
abnormalities, any prior bowel resection, or significant gastroparesis.
- Bowel preparation In the 2L-PEG/A group, 1 L of PEG containing ascorbic acid was taken
at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The
second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy
examination, with an additional 500 mL of water. Each liter of preparation and the
extra 500 mL water had to be consumed within 2 h of the procedure.
The 1L-PEG/AB group received 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy.
Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was
taken, followed by an additional 1 L of water. The preparation was completed 2 h before the
examination. All colonoscopies were performed between 9 am and 1 pm.
- Assessment by endoscopists Colonoscopies were performed by two expert endoscopists who
were blinded to the preparation regimen. These two endoscopists worked for more than 5 years
at our institution.
Bowel cleansing was scored by the same endoscopist performing the colonoscopy. To assess the
cleansing quality of the bowel preparations, the Boston Bowel Preparation Scale (BBPS) and
the Aronchick Bowel Preparation Scale (ABPS) were used.
- Assessment of patient tolerability and adverse events Before the colonoscopy procedure,
patients completed questionnaires about their symptoms associated with the preparations to
assess tolerability. Patients were asked to assess the degree of abdominal fullness,
abdominal pain, nausea, vomiting, sleep disturbances, and general discomfort using a 5-point
scale (i.e., none, mild, moderate, severe, or very severe).
The palatability of the preparation was graded in 5 categories: very good, good, acceptable,
disgusting, and bad.
- Sample size and statistical analysis A sample size of at least 89 patients group was
required for each treatment group to detect a difference in treatment success of a 5% type-I
error rate and 80% power for a two-tailed χ2 test. Our sample size was based on the results
from a pilot study that was conducted in our hospital and included 35 patients in each
group. It was estimated that the efficacy for excellent treatment success would be 49% with
PEG-2L/A and 30% with PEG-1L/AB. Based on these data, we decided to collect 100 patients per
treatment group for study.
Continuous variables were expressed as mean ± standard deviation (SD), and discontinuous
variables were expressed as counts and percentages. SPSS 20.0 for Windows (SPSS Inc.,
Chicago, IL, US) was used for data entry and statistical analyses. For the analyses between
the two treatment groups, Students t-test as appropriate was used to compare continuous
variables and either the Chi-square or Fisher's exact test were used for categorical data.
The p-values < 0.05 were considered statistically significant.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
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