Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting

NCT ID: NCT02839824

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

412 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-15

Study Completion Date

2017-03-06

Brief Summary

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Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials.

For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.

Detailed Description

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Bowel preparation

Bowel preparation for bowel cleansing in a real clinical practice

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years
* Subjects who have been performed a colonoscopy

Exclusion Criteria

* Subjects being previously performed colon surgery.
* Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy.
* Subjects with extreme limitations due to disease.
* Subjects in who Boston Bowel Preparation Scale (BBPS) is not available
* Subjects who have undergone a colonoscopy during their participation in another clinical study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Casen Recordati S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Bargalló, MD

Role: STUDY_DIRECTOR

Clínica de Medicina Integral Diagonal, Gastroenterology department

Locations

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Clínica de Medicina Integral Diagonal

Esplugues de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CAS-EVA-2016-01

Identifier Type: -

Identifier Source: org_study_id

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