Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified August 2022 by Hospital Clinic of Barcelona
Sponsor
Hospital Clinic of Barcelona
Information Provided by (Responsible Party)
María Pellisé
Clinicaltrials.gov Identifier
NCT04297423
Other Study ID Numbers:
HCB/2019/0872
First Submitted
March 3, 2020
First Posted
March 4, 2020
Last Update Posted
September 8, 2022
Last Verified
August 2022

ClinicalTrials.gov processed this data on September 2022. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Colorectal Cancer
Drug: PlenvuDrug: Plenvu

Study Design

Study TypeInterventional
Actual Enrollment1002 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeSupportive Care
Official TitleEficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado
Study Start DateMarch 10, 2020
Actual Primary Completion DateJune 27, 2022
Actual Study Completion DateJune 27, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Plenvu
Plenvu split dose
Drug: Plenvu
randomization 1:1
Citrafleet
citrafleet in split dose
Drug: Plenvu
randomization 1:1

Outcome Measures

Primary Outcome Measures
  1. Adenoma detection rate
    The percentage of patients with at least one adenoma in relation to the total subjects in each group of study
Secondary Outcome Measures
  1. 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.
  2. Lesion detection rate
    The percentage of patients with at least one polyp in relation to the total subjects in each group
  3. Caecal intubation rate
    If the caecum has been reached in the colonoscopy, it will be considered complete; otherwise, it will be considered incomplete
  4. 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
  5. 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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsHospital Clinic of Barcelona
Locations
Hospital CLinic | Barcelona Catalonia, Spain, 08036