Colorectal cancer is the first neoplasm most commonly diagnosed in both sexes and the second leading cause of cancer death in Spain. Colorectal cancer screening Program in Barcelona was implanted in 2009 and approximately 1,500 colorectal cancer screening colonoscopies are performed annually at Hospital Clínic de Barcelona. Adequate colon preparation (anterograde cleansing with laxatives) improves polyp detection, decreases examination time, and complications. There are both low and high volume intestinal regimens with polyethylene glycol (PEG) as the main active ingredient or without it. Hypothesis: Two low volumen regimens, 1L PEG plus ascorbate and magnesium citrate plus picosulphate, at starting doses have the same Adenoma Detection Rate as cleansing solutions in preparation for screening colonoscopy.
The primary objective of the study is to compare the clinical efficacy (by comparing the adenoma detection rate) of 1L PEG plus ascorbate versus magnesium citrate plus picosulphate in subjects undergoing colonoscopy in a colorectal cancer screening programme. We also will compare the Lesion Detection Rate, the quality of colon cleansing (Boston classification) overall and by segments, the tolerability and satisfaction and the rate of adverse effects experienced with intake of these products. Methodology: A comparative, parallel, randomized, single-centre, low-intervention clinical trial to be conducted at the CCR screening unit of Hospital Clínic de Barcelona that will include 1,002 participants. Subjects will complete a Tolerability and Satisfaction Questionnaire after completing the bowel preparation. Findings (polyps, CRC, or other lesions) and quality of bowel cleansing will be collected from the colonoscopy report.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,002
randomization 1:1
Hospital CLinic
Barcelona, Catalonia, Spain
Adenoma detection rate
The percentage of patients with at least one adenoma in relation to the total subjects in each group of study
Time frame: 2 years
Colonoscopy quality
Colonoscopy quality is assess with Boston Bowel Preparation Scale (BBPS) in which each colon segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). It will be considered adequate when each segment is scored ≥2.
Time frame: 2 years
Lesion detection rate
The percentage of patients with at least one polyp in relation to the total subjects in each group
Time frame: 2 years
Caecal intubation rate
If the caecum has been reached in the colonoscopy, it will be considered complete; otherwise, it will be considered incomplete
Time frame: 2 years
Rate of adverse events related to the administration of the preparation
Evaluated with the Tolerability and Satisfaction Questionnaire including symptoms such as nausea, vomiting, abdominal pain, bloating, headache, chills, dizziness, and dry mouth
Time frame: 2 years
Tolerability and satisfaction with preparation
Assessed by completing a tolerability and satisfaction questionnaire that has been prepared from the validated questionnaire Mayo Clinic Bowel Prep Tolerability Questionnaire (Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep; 46(9):808-12.doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19. PubMed PMID: 24953203) and which has been adapted and translated into Spanish
Time frame: 2 years
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