An observational study in Bowel Preparation, sponsored by Azienda USL Modena. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Azienda USL Modena · Observational
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.
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
Azienda USL Modena is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Only consecutive patients taking Plenvu (1L-PEG-Asc, Norgine, Harefield, UK) or Moviprep (2L-PEG-Asc, Norgine, Harefield, UK) were considered in our analyses, from January 2019 to September 2020
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Exclusion Criteria:
patients taking very low-volume 1L-PEG plus ascorbate (plenvu) for open access colonoscopy
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 taking low-volume 2L-PEG plus ascorbate (moviprep) for open access colonoscopy
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.
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.
Time frame: from January 2019 to September 2020
Tolerability was evaluated as the compliance to full BP intake.
it was recorded for evert patient before the beginning of colonoscopy
Time frame: from January 2019 to September 2020
Plan to share: No
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Azienda USL Modena