Bowel preparation with either novel 1L PEG+Asc or 2L PEG+Asc solution: a multicenter, randomized study in elderly outpatients: the PLATONE Study. - PLATONE (PLenvu Aigo TO Non-hospitalized Elderly)

AIGO - Associazione Italiana Gastroenterologi ed Endoscopisti DIgestivi Ospedalieri0 sites500 target enrollmentJune 4, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bowel preparation for diagnostic / operative colonscopy in outpatient
Sponsor: AIGO - Associazione Italiana Gastroenterologi ed Endoscopisti DIgestivi Ospedalieri
Enrollment: 500
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

June 4, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AIGO - Associazione Italiana Gastroenterologi ed Endoscopisti DIgestivi Ospedalieri

•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

•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.