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

Norgine

Status: Completed

Conditions: Colon Cleansing; Colon Disease; Colon Cancer

Treatments: Drug: 1L PEG + ASCORBIC ACID

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05174845

PLEN-01/2021

Details and patient eligibility

About

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

Full description

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.

Enrollment: 13,393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• History of colorectal cancer o colectomy before the first colonoscopy
• Impossibility to obtain the required mandatory data