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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Colon Cancer, Colon Disease, Colon Cleansing

Intervention / Treatment
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* Drug: 1L PEG + ASCORBIC ACID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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) |