Colon Cancer, Colon Cleansing, Colon Disease
Conditions
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.
Interventions
DRUG1L 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.
Sponsors
Xolomon Tree S.L.
Norgine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| Withdrawal time | Up to 2 days (from day of first dosing to day of colonoscopy) | Defined as the minutes spent inspecting the colon wall. |
| 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 |
| Safety of the preparation | Up to 2 days (from day of first dosing to day of colonoscopy) | Safety from registered adverse effects. |
| 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 |
| Treatment satisfaction, if available | Up to 2 days (from day of first dosing to day of colonoscopy) | Percentage of patients satisfied with the preparation |
| Tolerability of the preparation, if available | Up to 2 days (from day of first dosing to day of colonoscopy) | Defined as good, fair or poor. |
Countries
Portugal, Spain
Outcome results
None listed