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
NCT number | NCT05174845 |
Other study ID # | PLEN-01/2021 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | March 1, 2022 |
Verified date | May 2022 |
Source | Norgine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.
Status | Completed |
Enrollment | 13393 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Norgine | Xolomon Tree S.L. |
Portugal, Spain,
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) |
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