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

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.

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Key information

Conditions

Bowel Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda USL Modena

Carpi, Modena, 41012, Italy

About this study

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

Who can participate

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

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

Treatment and study plan

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

Other

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.

Primary outcomes

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.

Time frame: from January 2019 to September 2020

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.

Secondary outcomes

Tolerability was evaluated as the compliance to full BP intake.

Time frame: from January 2019 to September 2020

it was recorded for evert patient before the beginning of colonoscopy

Sponsors and collaborators

Lead sponsor

Azienda USL Modena

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jul 21, 2021
Registry last updated: Mar 3, 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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