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

Sponsor
Norgine (Industry)
Overall Status
Completed
CT.gov ID
NCT05174845
Collaborator
Xolomon Tree S.L. (Other)
13,393
12
5
1116.1
225

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 1L PEG + ASCORBIC ACID

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.

Study Design

Study Type:
Observational
Actual Enrollment :
13393 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official 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
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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 Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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.

  5. Withdrawal time [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 [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 [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. [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital da Senhora da Oliveira Guimarães Portugal
2 Hospital CUF Descobertas Lisboa Portugal
3 Consorci Corporació Sanitària Parc Taulí Sabadell Barcelona Spain
4 Hospital San Rafael A Coruña Spain
5 HM Sant Jordi Barcelona Spain
6 Hospital del Mar Barcelona Spain
7 Hospital Doctor López Cano Cadiz Spain
8 Complejo hospitalario Ruber Juan Bravo Madrid Spain
9 Hospital Clinico San Carlos Madrid Spain
10 Hospital La Zarzuela Madrid Spain
11 Hospital Quirón salud Sagrado Corazón Sevilla Spain
12 Consorcio Hospitalario Provincial de Castelló Valencia Spain

Sponsors and Collaborators

  • Norgine
  • Xolomon Tree S.L.

Investigators

  • Principal Investigator: Jose Miguel Esteban López-Jamar, MD, Norgine Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norgine
ClinicalTrials.gov Identifier:
NCT05174845
Other Study ID Numbers:
  • PLEN-01/2021
First Posted:
Jan 3, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022