Eficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 products (gastric emptying disorders, perforation or gastrointestinal obstruction, ileus, toxic megacolon).
- •People with congestive heart failure
- •Hypermagnesemia
- •Rhabdomyolysis
- •Phenylketourine
- •Glucose-6-phosphate dehydrogenase deficiency
- •People with hypersensitivity to the active ingredients of excipients
- •People with severe renal impairment
研究组 & 干预措施
Plenvu
Plenvu split dose
干预措施: Plenvu (Drug)
Citrafleet
citrafleet in split dose
干预措施: Plenvu (Drug)
结局指标
主要结局
Adenoma detection rate
时间窗: 2 years
The percentage of patients with at least one adenoma in relation to the total subjects in each group of study
次要结局
- Rate of adverse events related to the administration of the preparation(2 years)
- Colonoscopy quality(2 years)
- Lesion detection rate(2 years)
- Caecal intubation rate(2 years)
- Tolerability and satisfaction with preparation(2 years)
研究者
María Pellisé
Principal Investigator. Attending physician Gastroenterology department.
Hospital Clinic of Barcelona