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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174845
• Other study ID #: PLEN-01/2021
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2022
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 13393
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colon Cleansing
• Colon Disease
• Colonic Diseases

Intervention

Drug:
• 1L PEG + ASCORBIC ACID
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Norgine	Xolomon Tree S.L.

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Withdrawal time	Defined as the minutes spent inspecting the colon wall.	Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Treatment satisfaction, if available	Percentage of patients satisfied with the preparation	Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary	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)
Secondary	Safety of the preparation	Safety from registered adverse effects.	Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary	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)
Secondary	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)