Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia
- Conditions
- Colon DiseaseColon CleansingColon Cancer
- Registration Number
- NCT05174845
- Lead Sponsor
- Norgine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13393
- 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.
- History of colorectal cancer o colectomy before the first colonoscopy
- Impossibility to obtain the required mandatory data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens) Up to 2 days (from day of first dosing to day of colonoscopy) Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3.
Number of patients With Successful Bowel Cleansing (Overall Colon) Up to 2 days (from day of first dosing to day of colonoscopy) 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).
- Secondary Outcome Measures
Name Time Method Withdrawal time Up to 2 days (from day of first dosing to day of colonoscopy) Defined as the minutes spent inspecting the colon wall.
Tolerability of the preparation, if available Up to 2 days (from day of first dosing to day of colonoscopy) Defined with a semi-quantitative scale of 1-5 (1 = totally agree, 2 = agree, 3 = Neutral, 4 = disagree, 5 = totally disagree)
Polyps Detection Rate in the total colon and in the right colon Up to 2 days (from day of first dosing to day of colonoscopy) Proportion of colonoscopies where at least one polyp was found and removed in total and right colon
Adherence to the preparation, if available. Up to 2 days (from day of first dosing to day of colonoscopy) Percentage of patients with adherence to the preparation, defined as ingestion of at least 75% of each of the two doses
Safety of the preparation Up to 2 days (from day of first dosing to day of colonoscopy) Safety from registered adverse effects.
Treatment satisfaction, if available Up to 2 days (from day of first dosing to day of colonoscopy) Percentage of patients satisfied with the preparation
Sub-analyzes will be conducted in different patient populations Up to 2 days (from day of first dosing to day of colonoscopy) Patients ≥ 65 years, patients with chronic constipation, with diabetes mellitus, with hypertension, with mild to moderate renal failure and with inflammatory bowel disease.
Sub-analyzes of the primary and secondary outcomes Up to 2 days (from day of first dosing to day of colonoscopy) Sub-analyzes will be carried out by country, by the reason for the colonoscopy and by the recommended dietary regimen
Adenoma Detection Rate in the total colon and in the right colon Up to 2 days (from day of first dosing to day of colonoscopy) Proportion of colonoscopies where at least one adenoma is found based on histological analysis in total and right colon
Cecal intubation rate Up to 2 days (from day of first dosing to day of colonoscopy) Defined as the visualization of the ileocecal valve and / or appendicular orifice
Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline Up to 2 days (from day of first dosing to day of colonoscopy) Quality of the preparation (BBPS\> 2 in all colon segments) depending on the dietary guideline
Cecal intubation time Up to 2 days (from day of first dosing to day of colonoscopy) Defined as the time required for the introduction of the colonoscope to reach the base of the cecum.
Trial Locations
- Locations (12)
Hospital San Rafael
🇪🇸A Coruña, Spain
HM Sant Jordi
🇪🇸Barcelona, Spain
Consorci Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Doctor López Cano
🇪🇸Cadiz, Spain
Hospital La Zarzuela
🇪🇸Madrid, Spain
Complejo hospitalario Ruber Juan Bravo
🇪🇸Madrid, Spain
Consorcio Hospitalario Provincial de Castelló
🇪🇸Valencia, Spain
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
Hospital da Senhora da Oliveira
🇵🇹Guimarães, Portugal
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Quirón salud Sagrado Corazón
🇪🇸Sevilla, Spain