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

Norgine13,393 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

13,393

Conditions

Colon Cancer Colon Disease Colon Cleansing

Interventions

1L PEG + ASCORBIC ACIDDRUG

* 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Hospital da Senhora da Oliveira

Guimarães, Portugal

Hospital CUF Descobertas

Lisbon, Portugal

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Outcomes

Primary Outcomes

Number of patients With Successful Bowel Cleansing (Overall Colon)

The proportion of patients with adequate total colon cleansing is defined as a Boston Bowel preparation scale (BBPS) score ≥ 2 in all segments (BBPS\> 6).