2.1. Study design and data collection
We conducted a retrospective and descriptive study, based on a
prospective database, of pediatric patients treated with PDO stents in
our Unit from March 2012 to November 2023 (11 years and 8 months). We
retrieved and handled data through the Research Electronic Data Capture
(REDCap) system of our institution. The REDCap is a secure online
application developed to support data collection for research studies.
This study was approved by our Institutional Research Ethics Committee
and we obtained informed consent for all patients from their parents in
order to perform the endoscopic procedure and obtain photographic
content. The following data were collected in each case: demographics,
comorbidities, baseline respiratory status, indication for stenting,
stent size, anatomic location, insertion technique including the need
for balloon dilation, stent-related complications, need for re-stenting,
clinical result and time of follow-up. Main outcome measures were
related to the respiratory condition achieved after stenting (one or
more stents):
- Resolution : stenting permits withdrawal of ventilatory support
and/or complete resolution of respiratory symptoms.
- Partial improvement : some degree of clinical improvement is
achieved, either milder respiratory obstructive episodes or a
decreased need for ventilatory support.
- Unchanged : clinical status similar to pre-stenting.
- Worsen : clinical condition aggravates after stenting.