Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy
LOWOL
Eficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado
1 other identifier
interventional
1,002
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 colorectal-cancer
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2022
CompletedSeptember 9, 2022
September 1, 2022
2.3 years
March 4, 2020
September 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
The percentage of patients with at least one adenoma in relation to the total subjects in each group of study
2 years
Secondary Outcomes (5)
Colonoscopy quality
2 years
Lesion detection rate
2 years
Caecal intubation rate
2 years
Rate of adverse events related to the administration of the preparation
2 years
Tolerability and satisfaction with preparation
2 years
Study Arms (2)
Plenvu
EXPERIMENTALPlenvu split dose
Citrafleet
ACTIVE COMPARATORcitrafleet in split dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Casen Recordati S.L.collaborator
- Fundacion Clinic per a la Recerca Biomédicacollaborator
Study Sites (1)
Hospital CLinic
Barcelona, Catalonia, 08036, Spain
Related Publications (9)
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.
PMID: 24918005BACKGROUNDSchreiber S, Baumgart DC, Drenth JPH, Filip RS, Clayton LB, Hylands K, Repici A, Hassan C; DAYB Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):73-84. doi: 10.1055/a-0639-5070. Epub 2018 Jul 19.
PMID: 30025415BACKGROUNDBisschops R, Manning J, Clayton LB, Ng Kwet Shing R, Alvarez-Gonzalez M; MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):60-72. doi: 10.1055/a-0638-8125. Epub 2018 Jul 19.
PMID: 30025414BACKGROUNDDeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.
PMID: 28803744BACKGROUNDSeo SI, Kang JG, Kim HS, Jang MK, Kim HY, Shin WG. Efficacy and tolerability of 2-L polyethylene glycol with ascorbic acid versus sodium picosulfate with magnesium citrate: a randomized controlled trial. Int J Colorectal Dis. 2018 May;33(5):541-548. doi: 10.1007/s00384-018-2989-7. Epub 2018 Mar 1.
PMID: 29497812BACKGROUNDLee 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.
PMID: 28830134BACKGROUNDLai 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.
PMID: 19136102BACKGROUNDPatel 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.
PMID: 24953203BACKGROUNDGuillaumes S, O'Callaghan CA. [Spanish adaptation of the free OxMaR software for minimization and randomization of clinical studies]. Gac Sanit. 2019 Jul-Aug;33(4):395-397. doi: 10.1016/j.gaceta.2018.07.013. Epub 2018 Nov 1. Spanish.
PMID: 30390995BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator. Attending physician Gastroenterology department.
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 5, 2020
Study Start
March 11, 2020
Primary Completion
June 28, 2022
Study Completion
June 28, 2022
Last Updated
September 9, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share