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NCT04970173 Clinical Trial

1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events

Bowel Preparation Clinical Trial

Official title:
1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04970173
Other study ID # 01-2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date September 30, 2020

Study information
Verified date July 2021
Source Azienda USL Modena
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Several trials have demonstrated the efficacy and safety of low volume 2L-PEG based regimens compared with high volume PEG regimens and non-PEG agents. However, for low-volume 1L-PEG plus ascorbate (1L-PEG-Asc) only the data from registration trials are available, and none of these have been performed in an "open access" colonoscopy booking system. The aim of our study was to evaluate the safety and tolerability of 1L-PEG-Asc compared to 2L-PEG plus ascorbate (2L-PEG-Asc) in an "open access" booking system.

Description:

All patients who underwent "open access" colonoscopy in our Unit from January 2019 to September 2020 were evaluated as part of a quality improvement project. Only patients taking 2L-PEG-Asc and 1L-PEG-Asc were enrolled in this study. Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. Tolerability was evaluated as the compliance to full BP intake

Recruitment information / eligibility
Status Completed
Enrollment 5981
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - From January 2019 to September 2020, data from all consecutive adult (aged = 18 years old) patients who underwent "open access" colonoscopy performed in our Digestive Endoscopy Unit (which is based in the Hospitals of Carpi, Castelfranco Emilia, Mirandola, Pavullo and Vignola) were collected using an electronic reporting system Exclusion Criteria: - Pregnant of breastfeeding patients

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopy
Patients are free to choice the kind of BP in an open access booking system colonoscopy. The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals.

Locations
Country Name City State
Italy Azienda USL Modena Carpi Modena

Sponsors (1)
Lead Sponsor Collaborator
Azienda USL Modena

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals. from January 2019 to September 2020
Secondary Tolerability was evaluated as the compliance to full BP intake. it was recorded for evert patient before the beginning of colonoscopy from January 2019 to September 2020
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