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

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

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

Study Overview

• Status: Completed
• Conditions: Colon Cancer; Colon Disease; Colon Cleansing
• Intervention / Treatment: Drug: 1L PEG + ASCORBIC ACID

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.

• Study Type: Observational
• Enrollment (Actual): 13393

Contacts and Locations

Study Locations

• Portugal
  • Guimarães, Portugal
    • Hospital da Senhora da Oliveira
  • Lisboa, Portugal
    • Hospital CUF Descobertas
• Spain
  • A Coruña, Spain
    • Hospital San Rafael
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • HM Sant Jordi
  • Cadiz, Spain
    • Hospital Doctor López Cano
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital la Zarzuela
  • Madrid, Spain
    • Complejo Hospitalario Ruber Juan Bravo
  • Sevilla, Spain
    • Hospital Quirón Salud Sagrado Corazón
  • Valencia, Spain
    • Consorcio Hospitalario Provincial de Castelló
  • Barcelona
    • Sabadell, Barcelona, Spain
      • Consorci Corporació Sanitària Parc Taulí

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 2 days (from day of first dosing to day of colonoscopy)
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)	Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3.	Up to 2 days (from day of first dosing to day of colonoscopy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyps Detection Rate in the total colon and in the right colon	Proportion of colonoscopies where at least one polyp was found and removed in total and right colon	Up to 2 days (from day of first dosing to day of colonoscopy)
Adenoma Detection Rate in the total colon and in the right colon	Proportion of colonoscopies where at least one adenoma is found based on histological analysis in total and right colon	Up to 2 days (from day of first dosing to day of colonoscopy)
Cecal intubation rate	Defined as the visualization of the ileocecal valve and / or appendicular orifice	Up to 2 days (from day of first dosing to day of colonoscopy)
Cecal intubation time	Defined as the time required for the introduction of the colonoscope to reach the base of the cecum.	Up to 2 days (from day of first dosing to day of colonoscopy)
Withdrawal time	Defined as the minutes spent inspecting the colon wall.	Up to 2 days (from day of first dosing to day of colonoscopy)
Tolerability of the preparation, if available	Defined as good, fair or poor.	Up to 2 days (from day of first dosing to day of colonoscopy)
Tolerability of the preparation, if available	Defined with a semi-quantitative scale of 1-5 (1 = totally agree, 2 = agree, 3 = Neutral, 4 = disagree, 5 = totally disagree)	Up to 2 days (from day of first dosing to day of colonoscopy)
Adherence to the preparation, if available.	Percentage of patients with adherence to the preparation, defined as ingestion of at least 75% of each of the two doses	Up to 2 days (from day of first dosing to day of colonoscopy)
Treatment satisfaction, if available	Percentage of patients satisfied with the preparation	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	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)
Safety of the preparation	Safety from registered adverse effects.	Up to 2 days (from day of first dosing to day of colonoscopy)
Sub-analyzes will be conducted in different patient populations	Patients ≥ 65 years, patients with chronic constipation, with diabetes mellitus, with hypertension, with mild to moderate renal failure and with inflammatory bowel disease.	Up to 2 days (from day of first dosing to day of colonoscopy)
Sub-analyzes of the primary and secondary outcomes	Sub-analyzes will be carried out by country, by the reason for the colonoscopy and by the recommended dietary regimen	Up to 2 days (from day of first dosing to day of colonoscopy)

Collaborators and Investigators

• Sponsor: Norgine
• Collaborators: Xolomon Tree S.L.
• Investigators: Principal Investigator: Jose Miguel Esteban López-Jamar, MD, Norgine Spain

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: PLEN-01/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No