utility study of a predictive system for ambulatory colonoscopy preparatio

Phase 1

Conditions: Colonoscopia ambulatoria
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2017-000787-15-ES

Lead Sponsor: Antonio Zebenzui Gimeno García

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

Patients 18-85 years old
Ambulatory candidates to colonoscopy
Informe consent signed
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

colonic or small bowel resection, gastroparesia, pseudo obstruction, megacolon, bowel perforation, uncontrolled hypertension, CCI, CKF, pregnants, knowed hypersensibility to components, dementia with dysphagia, previous inclusión in the study, Boston scale under 6points in previous test

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare teh efficacy of two stategies of colonic preparation ;Secondary Objective: 1) Evaluate the utility of a system to allocate strategies for colonic preparation for colonoscopy<br>2) To compare the level of tolerance between two types of colonic preparation<br>3) To compare the rate of detection of different types of polyps with two types of preparation;Primary end point(s): colonic preparation with Boston scale;Timepoint(s) of evaluation of this end point: during coloscopy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): tolerance, predisposition to repeat, swelling difficulties, detection of colonic lesions;Timepoint(s) of evaluation of this end point: colonoscopy