Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia

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

13393 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-03-01

Brief Summary

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A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.

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Detailed Description

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Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data).

The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.

Conditions

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Colon Cancer Colon Disease Colon Cleansing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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1L PEG + ASCORBIC ACID

* 2-Day Split-Dosing: The patient has taken the product in the evening before the scheduled colonoscopy and mandatory additional clear fluid. The patient has taken the second dose with mandatory additional clear fluids on the morning of the colonoscopy.
* Same Day: The patient has taken the first dose of the product on the day of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break, the patient has taken a second dose plus additional clear mandatory fluid.

Intervention Type DRUG

Other Intervention Names

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PLENVU NER1006 PLEINVUE

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021
* Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day.