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sefulness of strengthering the bowel-cleansing preparation in patients with weak previous colonoscopy preparatio

Phase 1
Conditions
Colorectal cancer
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
MedDRA version: 21.0 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations
MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Registration Number
EUCTR2019-001277-93-ES
Lead Sponsor
Príncipe de Asturias University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Not specified
Target Recruitment
44
Inclusion Criteria

- Subjects that have been previously included in the polyps follow-up program (screening) of the high-risk colorectal cancer.
- Subjects over 18 and under 80 years of age.
- Subjects who, after performing a correct previous preparation, present insufficient cleaning on the colonoscopy (score on the Boston scale of less than 2 in each segment of the colon).
- Subjects that agree to participate and sign the informed Consent.
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

- Patients with intestinal resections
- Patients with Inflammatory Bowel Disease
- Hospitalized patients
- Patients with intolerance or allergy to Macrogol 3350
- Patients who prefer another type of preparation that is not a Bohm® evacuating solution

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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