Clinical trial NCT04297423: Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy
Official title: Eficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: Bowel Preparation Solutions
Screening colonoscopy
Adenoma detection rate
Tolerability
1L PEG plus ascorbate
Magnesium citrate plus picosulphate
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Casen Recordati S.L.
name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2020-03-05
Enrollment: 1002
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A comparative, parallel, randomized, non-inferiority, non-blinded, single-centre and low-intervention clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 2 years
Secondary outcomes:
measure: Colonoscopy quality
timeFrame: 2 years
measure: Lesion detection rate
timeFrame: 2 years
measure: Caecal intubation rate
timeFrame: 2 years
measure: Rate of adverse events related to the administration of the preparation
timeFrame: 2 years
measure: Tolerability and satisfaction with preparation
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital CLinic
state: Catalonia
Study officials:
References:
citation: Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200.
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citation: Lee SW, Bang CS, Park TY, Suk KT, Baik GH, Kim DJ. Split-dose Bowel Preparation for Colonoscopy: 2 Liters Polyethylene Glycol with Ascorbic Acid versus Sodium Picosulfate versus Oral Sodium Phosphate Tablets. Korean J Gastroenterol. 2017 Aug 25;70(2):89-95. doi: 10.4166/kjg.2017.70.2.89.
citation: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
citation: 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.
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