Study design
Prospective, observational, single-centre Italian study.
Aim
To evaluate the incidence of adverse events (AEs) following bowel preparation with 1L PEG-ASC or 2L PEG-ASC solutions.
Patients
A total of 5,981 consecutive outpatients aged ≥18 years who underwent ‘open access’ colonoscopy in a single Italian centre, across 5 hospitals, between January 2019 to September 2020.
Treatments
Patients independently selected one of two bowel cleansing preparations, either in a same-day or spilt-dose regimen:
Endpoints
AE occurrence was assessed by reviewing the clinical and laboratory data of patients in the 7 days post-colonoscopy.
AEs were independently evaluated by a physician panel that determined whether AEs were:
- Bowel preparation-related: tachyarrhythmia, syncope, electrolyte abnormalities, renal function impairment and peripheral oedema
- Bowel preparation-unrelated AEs included abdominal pain and nausea when these were the main symptoms responsible for patients attending the Emergency Department of the hospital.
Statistical analysis
Continuous data were expressed as mean and standard deviation with categorical data expressed as a percentage.
