Split dose bowel cleansing for colonoscopy
Conditions
Interventions
Trade Name: Moviprep
Pharmaceutical Form:
Sponsors
Ospedale Valduce
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: asymptomatic subjects aged 50-69 participating to regional screening program and undergoing outpatient colonoscopy for positive immunologic fecal occult blood test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: - patients undergoing colonoscopy as primary screening test - patients undergoing colonoscopy for symptoms or post-polipectomy/ cancer surveillance - patients with history of negative large bowel endoscopy within the previous 5 years - patients with personal history of hereditary syndromes – FAP, HNPCC - patients with history of colonic resection and inflammatory bowel disease - patients with a history of radiation therapy to abdomen or pelvis - patients with a history of severe cardiovascular, pulmonary, liver or renal disease - patients with unstable psychiatric illness - patients at risk for inhalation - patients on ant-platelet therapy or anticoagulation at the time of endoscopy procedure, preventing polyp resection - patient with known hypersensitivity or contraindications (i.e., patients with phenylketonuria or glucose-6-phosphate dehydrogenase deficiency) to the study product - patients who are not able or refuse to provide informed written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This randomized controlled trial is designed to test the hypothesis that split-dosing low-volume polyethylene-glycol solution can increase the adenoma detection in patients undergoing screening colonoscopy;Secondary Objective: None;Primary end point(s): Proportion of patients with at least one adenoma (adenoma detection rate) ;Timepoint(s) of evaluation of this end point: End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall quality of bowel preparation, as assessed by the endoscopists by the Harefield Cleansing Scale (HCS) - Quality of bowel preparation for the right colon - Proportion of patients with at least one advanced adenoma (adenoma > 10mm, and/or villous component, and/or high grade dysplasia) - Proportion of patients with at least one flat/depressed adenoma, according to Paris classification - Proportion of patients with at least one proximal sessile serrated adenoma/polyp - Number of total adenomas, advanced adenomas, proximal adenomas, proximal advanced adenomas, flat/depressed adenomas - Patient tolerability and acceptability, as assessed by a nurse before colonoscopy ;Timepoint(s) of evaluation of this end point: End of the study | — |
Countries
Italy
Contacts
Public ContactGastroenterology Unit
Ospedale Valduce
Outcome results
None listed