An interventional study of Split dose low-volume PEG solution in Colonic Adenomas, sponsored by Valduce Hospital. Status unknown at 2 sites in Italy. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2014-06-30.
Sponsored by Valduce Hospital · Not applicable, Interventional, and Diagnostic
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.
Valduce Hospital is the lead sponsor of 29 studies on the registry; none are open to participants now.
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All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®\*, Norgine, Harefield, United Kingdom); Bowel cleansing preparation is divided into two equal doses (each MOVIPREP® sachet dissolved in one liter of water, according to manufacturer's instruction). Each dose must be followed by at least 0.5 L of clear fluid at each administration, and should be taken in a maximum time of 2 hours. In this arm, both doses are taken the day before colonoscopy, starting on the evening at about 18:00. Solution intake should be completed before 22.00 h.
Drug: Split dose low-volume PEG solution
All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®\*, Norgine, Harefield, United Kingdom); Bowel cleansing preparation is divided into two equal doses (each MOVIPREP® sachet dissolved in one liter of water, according to manufacturer's instruction). Each dose must be followed by at least 0.5 L of clear fluid at each administration, and should be taken in a maximum time of 2 hours. In this arm, the first dose is taken on the evening before colonoscopy (at about 20:00 h), the second one is taken early in the morning on the day of the procedure, starting about 4 h before the scheduled procedure time.
Drug: Split dose low-volume PEG solution
All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®, Norgine, Harefield, United Kingdom); in the "control arm" the whole colonoscopy preparation is administered the day before colonoscopy; in the " active comparator " arm one liter of the bowel preparation is administered on the evening before the colonoscopy and the remaining liter on the day of the procedure.
Also known as: Low-volumePEG solution used in this study: MOVIPREP®, Norgine, Harefield, United Kingdom
Adenoma Detection Rate
Proportion of patients with at least one adenoma
Time frame: 1 year
Advanced Adenoma Detection Rate
Number of patients with at least one advanced adenoma (adenoma\> or =10mm and/or villous component and/or high grade dysplasia)
Time frame: 1 year
Flat/depressed Adenoma Detection Rate
proportion of patients with at least one flat/depressed adenoma
Time frame: 1 year
Proximal sessile serrated lesion detection rate
Proportion of patients with at least one proximal sessile serrated lesion
Time frame: 1 year
Number of adenomas per patient
Number of adenomas per patient
Time frame: 1 year
Number of advanced adenomas per patient
Number of advanced adenomas per patient
Time frame: 1 year
Number of proximal adenomas
Number of adenomas located in the proximal colon (right and transverse colon)
Time frame: 1 year
Quality of bowel preparation
Quality of bowel cleansing measured by the Boston Bowel Preparation Scale
Time frame: 1 year
The record gives a start of Jan 2014, a primary completion of Dec 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
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Valduce Hospital