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| Name | Class |
|---|---|
| Xolomon Tree S.L. | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1L PEG + ASCORBIC ACID | Drug |
|
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006
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| Name | Affiliation | Role |
|---|---|---|
| Jose Miguel Esteban López-Jamar, MD | Norgine Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Senhora da Oliveira | Guimarães | Portugal | ||||
| Hospital CUF Descobertas |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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) |
| Lisbon |
| Portugal |
| Consorci Corporació Sanitària Parc Taulí | Sabadell | Barcelona | 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 |
| Hospital Quirón salud Sagrado Corazón | Seville | Spain |
| Consorcio Hospitalario Provincial de Castelló | Valencia | Spain |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |