An observational study in Obstructive Sleep Apnea, Postoperative Respiratory Complications and Adenotonsillectomy, sponsored by University Hospital, Antwerp. Recruiting at 2 sites in 2 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University Hospital, Antwerp · Observational
This retrospective observational study aims to evaluate postoperative respiratory complications (PORC) after (adeno)tonsillectomy in children with OSA.
In order to increase the number of patients available for analysis, we will merge data collected at UZA with data collected at the the Department of Sleep Laboratory and Sleep Surgery at the Heim Pal National Pediatric Institute, Hungary. These colleagues performed an identical prospective data collection.
This is a retrospective, multicenter cohort study using anonymized electronic health record data collected in a prospective study (PORC -EDGE 2364) performed at UZA and an identical prospective data collection performed by collegues at Department of Sleep Laboratory and Sleep surgery at Heim Pal National Pediatric Institute at Budapest.Data are collected from otherwise healthy children and children with varying comorbidities undergoing (adeno)-tonsillecty for Obstructive Sleepapnea (OSAS). Per-postoperative management was carried out according to a predefined treatment protocol.
As this study uses existing data, no informed consent was required. The aim of the current project is to answer the following questions.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 200 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
children with or without co-morbidities undergoing (adeno)tonsillectomy for OSAS during time frame of the study period
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children with OSA after (adeno)tonsillectomy
What is the prevalence of PORC in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition
Number of PORC
Time frame: 24 hours postoperative
Not enrolling at this site.
Started May 2022 (actual). Primary completion is estimated for Dec 2025, 43 months after the start.
How these figures are worked out, and which studies are left out of them.
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