Comparison between two bowel preparations (laxatives) of different volume in elderly people

Phase 1

• Conditions: Bowel preparation for diagnostic / operative colonscopy in outpatient; MedDRA version: 21.0Level: PTClassification code 10010011Term: Colonoscopy normalSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-000927-38-IT
• Lead Sponsor: AIGO - Associazione Italiana Gastroenterologi ed Endoscopisti DIgestivi Ospedalieri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified