Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy (NCT04297423) | Clinical Trial Compass
CompletedPhase 4
Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy
Spain1,002 participantsStarted 2020-03-11
Plain-language summary
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.
Who can participate
Age range
50 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women aged 50 to 69 years who have participated in the early detection programme for colon and rectal cancer (PDPCCR) in Barcelona, who have obtained a positive result in the faecal occult blood test (≥20 μg Hb/g faeces) and who are scheduled for a screening colonoscopy at Hospital Clínic de Barcelona.
Exclusion Criteria:
* People who do not agree to participate in the study.
* People with known severe renal failure (grade IV or V) and grade III and IV heart failure according to the New York Heart Association (NYHA) Scale of Functional Assessment of Heart Failure
* Individuals who have undergone a colonoscopy in the past year.
* Subjects meeting the Rome IV Criteria for the diagnosis of functional constipation
* Subjects with mental disabilities or with a severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders).
* Individuals who do not understand Catalan or Spanish verbally and in writing.
* Individuals with partial or total colon resection.
* Individuals with a personal history of CRC or colorectal disease amenable to specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
* Individuals with terminal illness or severe illness/disability that contraindicates further study of the colon.
* People with gastrointestinal disorders that contraindicate the use of the study produc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.