Colonic Adenomas Clinical Trial
Official title:
The Impact of Split Dose of Low-volume Polyethylene Glycol on Adenoma Detection Rate: a Randomized, Investigator Blind, Controlled Trial
An adequate level of bowel preparation is crucial for the efficacy and safety of
colonoscopy. Strong evidences suggest that bowel-preparation quality shows an inverse
correlation with length of the interval between the end of cleansing agent intake and the
start of colonoscopy (shorter intervals are associated with better preparation levels).
Accordingly, the use of a split-dose administration regimen has been demonstrated to
significantly improve the quality of preparation, besides patient acceptability, as compared
with standard administration the day before colonoscopy. All randomized controlled trials
comparing split versus standard preparations were primarily aimed at assessing the quality
of colon cleansing, by means of either validated or not-validated colon cleansing scales.
The impact of a split dose regimen on objective colonoscopy performance measures such as
adenoma detection rate (ADR) has never been specifically and prospectively evaluated.
The present study is aimed at evaluating whether the split-dose preparation regimen is
associated with an increase of adenoma detection.
For this purpose, asymptomatic subjects aged 50-69, undergoing screening colonoscopy for
positive immunologic fecal occult blood test are randomized in a 1:1 ratio to receive
low-volume (2L) PEG plus ascorbic acid solution either in a split-dose (study arm) or in a
full-dose regimen (control arm).
Treatments are allocated using a computer-generated, randomized code list. The treatment
allocation is concealed and is accomplished at the screening visit through non-research
personnel who is not involved in the study. To ensure masking, the endoscopists who perform
the colonoscopies are not involved in the randomization process and in the pre-procedure
data collection.
In this study the the primary outcome measure was the proportion of patients with at least
one adenoma (Adenoma Detection Rate) in each harm. Data on bowel cleansing, patient
compliance, tolerability and acceptability were also collected.
A sample size of at least 514 patients (257 in each arm) was calculated, by hypothesizing a
relative increase of 25% in the adenoma detection rate in the split dose preparation group,
assuming a 40% prevalence of one or more adenoma in FIT-positive patients undergoing
screening colonoscopy (significance level 0.05, 90% power).
All participants will receive the same low-volume (2L) PEG plus ascorbic acid solution
(MOVIPREP®*, Norgine, Harefield, United Kingdom; each liter containing 100.0 g macrogol
3350, 7.5 g sodium sulfate,2.7 g sodium chloride, 1.0 g potassium chloride, 4.7 g ascorbic
acid, 5.9 g sodium ascorbate, and lemon or orange flavoring).
Patients allocated in the "control arm" will receive the whole preparation the day before
colonoscopy, whereas, patient randomly allocated to the "active treatment" will take one
liter of the bowel preparation the evening before the procedure and the remaining liter the
day of the procedure.
Participants will also receive a standardized low-fiber diet before the colonoscopy,
avoiding fruit, legumes or vegetables for 3 days before the procedure. They will have a
normal breakfast and a light lunch on the day before the procedure, but no solid food will
be permitted since then. Liquid food (e.g., clear soup or yoghurt) will be permitted for the
evening meal. Clear fluids can be taken at any time, until 2 hours before the procedure.
Treatments are allocated using a computer-generated, randomized code list. The treatment
allocation is concealed and is accomplished at the screening visit through non-research
personnel who is not involved in the study. To ensure masking, the endoscopists who perform
the colonoscopies are not involved in the randomization process and in the pre-procedure
data collection.
Data on patient compliance, tolerability and acceptability are collected on the morning of
colonoscopy, immediately before the procedure, by a nurse questioned through a standardised
questionnaire. The endoscopist is not allowed to take part in the questioning or to
supervise the questionnaire.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
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