An observational study in Colon Cancer, Colon Disease and Colon Cleansing, sponsored by Norgine. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Norgine · Observational
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's enrollment of 13,393 is above the median of 262 across 363 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Norgine is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug pages: Polyethylene glycol 3350 · Ascorbic Acid · Sodium sulfate · Sodium Chloride · Potassium Chloride
* 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.
Also known as: PLENVU, NER1006, PLEINVUE
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).
Time frame: 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.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Withdrawal time
Defined as the minutes spent inspecting the colon wall.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Treatment satisfaction, if available
Percentage of patients satisfied with the preparation
Time frame: 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
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Safety of the preparation
Safety from registered adverse effects.
Time frame: 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.
Time frame: 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
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Ran from Oct 2021 to primary completion in Mar 2022, 5 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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