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Completed

NCT Number: NCT05174845

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

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

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Key information

Conditions

Colon Cancer Colon Cleansing Colon Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital da Senhora da Oliveira, Guimarães, Portugal

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1L PEG + ASCORBIC ACID

Drug
  • 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.

Other names: PLENVU, NER1006, PLEINVUE

Primary outcomes

  1. Number of patients With Successful Bowel Cleansing (Overall Colon)

    Time frame: 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).

  2. Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

    Time frame: 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 outcomes

  1. Polyps Detection Rate in the total colon and in the right colon

    Time frame: 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

  2. Adenoma Detection Rate in the total colon and in the right colon

    Time frame: 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

  3. Cecal intubation rate

    Time frame: 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

  4. Cecal intubation time

    Time frame: 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.

  5. Withdrawal time

    Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)

    Defined as the minutes spent inspecting the colon wall.

  6. Tolerability of the preparation, if available

    Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)

    Defined as good, fair or poor.

  7. Tolerability of the preparation, if available

    Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)

    Defined with a semi-quantitative scale of 1-5 (1 = totally agree, 2 = agree, 3 = Neutral, 4 = disagree, 5 = totally disagree)

  8. Adherence to the preparation, if available.

    Time frame: 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

  9. Treatment satisfaction, if available

    Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)

    Percentage of patients satisfied with the preparation

  10. 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)

    Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline

  11. Safety of the preparation

    Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)

    Safety from registered adverse effects.

  12. Sub-analyzes will be conducted in different patient populations

    Time frame: 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.

  13. Sub-analyzes of the primary and secondary outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norgine

Industry

Collaborators

  • Xolomon Tree S.L.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 3, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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