Bowel preparation for diagnostic / operative colonscopy in outpatient MedDRA version: 21.0 Level: PT Classification code 10010011 Term: Colonoscopy normal System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: PLENVU - POLVERE PER SOLUZIONE ORALE 1 BUSTINA PET/PE/AL DA 115,96 G + 1 BUSTINA A PET/PE/AL DA 46,26 G + 1 BUSTINA B PET/PE/AL DA 55,65 G (1 TRATTAMENTO)
Product Name: PLENVU
Product Code
Sponsors
AIGO - Associazione Italiana Gastroenterologi ed Endoscopisti DIgestivi Ospedalieri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in the study will be adult outpatients aged between 65 and 85 years undergoing scheduled elective colonoscopy in a hospital setting for indications including evaluation of gastrointestinal (GI) symptoms, screening, and polyp surveillance. Patients must provide written informed consent, and must be able to understand and comply with the instructions and to complete the entire study, Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: Patients will be excluded in case of: GI obstruction; toxic megacolon, or active GI bleeding; severe constipation (with regular use of laxatives – 2-3 times per week in the last month); previous history of colorectal resection; acute exacerbation of inflammatory bowel disease; liver cirrhosis with ascites (Child Pugh B or C); impaired renal function (eGFR<30 ml/min/1.73 m2); congestive heart failure (NYHA Class III - IV); cognitive impairment; phenylketonuria; G6PDH deficiency; active treatment for cardiovascular disease or ECG changes in the last 12 months (for example arrhythmias); thyroid disease, or electrolytic imbalance; treatment resistant hypertension (systolic BP =140 mm Hg; diastolic BP=90 mm Hg ); hypersensitivity or known allergy to PEG (or to any of the listed components), and generally according to contraindications, special warnings and precautions for use respective of both products; previous participation in a clinical trial with administration of investigational drug within 30 days or 5-half lives of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the overall bowel cleansing (Boston Bowel Preparation Scale – BBPS =6) success rate of 1L volume of Polyethylene glycol PEG 3350, Sodium Ascorbate, Sodium Sulfate (IMP Test) is not lower than that obtained using 2 l PEG+Asc (IMP Confronto), both in split dose, in elderly outpatients undergoing scheduled colonoscopy.;Secondary Objective: Secondary Endpoints are aimed to compare Plenvu vs Moviprep in terms of: •Colonoscopy performance indicators (points 1-2) •Cleansing performance on the right colon (point 3) •Evaluate the impact of the bowel preparation’s timing on the cleansing success(point 4) •Compliance, Tolerability and side effects assessed by patient reported outcome (points 5-10) 1) Cecal intubation rate, 2) ADR and PDR, 3) Adequate cleansing of right colon, 4) Differences in successful bowel cleansing between patients undergoing colonoscopy in the morning or in the afternoon, 5)Compliance with product intake, 6-7)Tolerability: a) first colonoscopy b) previous colonoscopy, 8) Intensity and rate of side effects, 9) Sleep quality, 10) Fecal incontinence during travel, 11) Willingness to repeat same prep in patients with previous colonscopy during the last 3 years;Primary end point(s): see above;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see above;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactS.O.C. Gastroenterologia Pistoia
Azienda USL Toscana Centro
Outcome results
None listed