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

Completed

• Conditions: Bowel Preparation
• Interventions: 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

• Registration Number: NCT04970173
• Lead Sponsor: Azienda USL Modena

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Study First Posted: 2021-07-21
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5981

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	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 taking very low-volume 1L-PEG plus ascorbate (plenvu) for open access colonoscopy
2	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 taking low-volume 2L-PEG plus ascorbate (moviprep) for open access colonoscopy

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
Tolerability was evaluated as the compliance to full BP intake.	from January 2019 to September 2020	it was recorded for evert patient before the beginning of colonoscopy

Trial Locations

Locations (1)

Azienda USL Modena; 🇮🇹 Carpi, Modena, Italy