Clinical trial NCT05174845: Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia
Official title: An Observational, Retrospective and Multicenter Study to Evaluate the Effectiveness and Safety of 1L (PEG)+ Ascorbic Acid Given for Bowel Preparation Prior to Colonoscopy in Iberia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Colon Disease
Colon Cleansing
Lead sponsor: Norgine
Sponsor class: INDUSTRY
Collaborators: name: Xolomon Tree S.L.
First posted: 2022-01-03
Enrollment: 13393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients With Successful Bowel Cleansing (Overall Colon)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary outcomes:
measure: Polyps Detection Rate in the total colon and in the right colon
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Adenoma Detection Rate in the total colon and in the right colon
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Cecal intubation rate
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Cecal intubation time
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Withdrawal time
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Tolerability of the preparation, if available
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Tolerability of the preparation, if available
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Adherence to the preparation, if available.
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Treatment satisfaction, if available
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Safety of the preparation
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Sub-analyzes will be conducted in different patient populations
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
measure: Sub-analyzes of the primary and secondary outcomes
timeFrame: Up to 2 days (from day of first dosing to day of colonoscopy)
Other outcomes:
Locations:
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí
state: Barcelona
city: A Coruña
country: Spain
facility: Hospital San Rafael
city: Barcelona
country: Spain
facility: HM Sant Jordi
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cadiz
country: Spain
facility: Hospital Doctor López Cano
city: Madrid
country: Spain
facility: Complejo hospitalario Ruber Juan Bravo
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital La Zarzuela
city: Sevilla
country: Spain
facility: Hospital Quirón salud Sagrado Corazón
city: Valencia
country: Spain
facility: Consorcio Hospitalario Provincial de Castelló
Study officials:
affiliation: Norgine Spain
name: Jose Miguel Esteban López-Jamar, MD
role: PRINCIPAL_INVESTIGATOR
References: