An observational study in Robotic Surgical Procedures, sponsored by Meyer Children's Hospital IRCCS. Not yet recruiting. Open to participants aged 0 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Meyer Children's Hospital IRCCS · Observational
This is a single-center retrospective observational cohort study evaluating surgical and clinical outcomes in pediatric patients undergoing robotic surgery at a tertiary children's hospital.
All consecutive patients younger than 18 years who underwent robotic-assisted procedures (digestive, urologic, gynecologic, or thoracic surgery) between January 2025 and December 2025 at Meyer Children's Hospital IRCCS will be included.
The primary objective is to describe postoperative complications within 30 days. Secondary objectives include conversion to open surgery, reintervention and readmission rates, length of hospital stay, postoperative pain, recovery parameters, and recurrence of the underlying disease within 12 months.
Data will be collected retrospectively from electronic medical records, operative registries, laboratory reports, and follow-up documentation up to 12 months after surgery.
Robotic-assisted surgery has progressively expanded in pediatric practice over the past two decades, particularly in urology and increasingly in general, thoracic, and gynecologic pediatric surgery. While several case series and meta-analyses have demonstrated feasibility and safety in selected procedures, real-world institutional data remain essential to evaluate performance, safety, and outcome variability across different surgical domains.
This study is a monocentric retrospective observational cohort conducted at Meyer Children's Hospital IRCCS. The study population includes all consecutive patients younger than 18 years who underwent robotic-assisted digestive, urologic, gynecologic, or thoracic surgical procedures between January 2025 and December 2025.
Clinical data will be extracted from routinely collected hospital records, including electronic medical charts, operative registries, laboratory and imaging reports, discharge summaries, and outpatient follow-up documentation.
The primary outcome is the occurrence of postoperative complications within 30 days, classified according to the Clavien-Dindo grading system when applicable.
Secondary outcomes include:
Conversion from robotic to open surgery
Reintervention within 30 days
Readmission within 30 days
Surgical site and nosocomial infections
Postoperative length of stay
Postoperative pain assessed by Visual Analog Scale (VAS) within the first 72 hours
Time to resumption of oral feeding and bowel function
Recurrence of the primary surgical condition within 12 months
Additionally, exploratory analyses will assess differences in outcomes across surgical specialties and evaluate potential factors associated with complications and prolonged hospitalization, including age, weight, comorbidities, procedural complexity, operative time, and conversion.
Data will be analyzed using appropriate descriptive and comparative statistical methods.
Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients undergoing robotic-assisted surgery at Meyer Children's Hospital IRCCS between January 2025 and December 2025.
Exclusion Criteria:
Pediatric patients (\<18 years) undergoing robotic surgery (digestive, urologic, gynecologic, or thoracic procedures) between January 2025 and December 2025 at Meyer Children's Hospital IRCCS.
Postoperative Complications Within 30 Days
Occurrence of postoperative complications within 30 days after robotic-assisted surgery, classified according to the Clavien-Dindo grading system when applicable and documented in the medical record.
Time frame: 30 days after surgery
Reintervention Rate
Unplanned surgical reintervention within 30 days after the index robotic-assisted procedure.
Time frame: 30 days after surgery
Hospital Readmission Rate
Unplanned hospital readmission occurring within 30 days after discharge from the index hospitalization.
Time frame: 30 days after discharge
Postoperative Pain (VAS Score)
Pain intensity measured using the Visual Analog Scale (VAS) every 6 hours during the first 72 postoperative hours, as recorded in routine clinical documentation.
Time frame: 72 hours after surgery
Time to Resumption of Oral Feeding
Time from surgery to resumption of oral feeding as documented in the medical record.
Time frame: Within 48 hours after surgery
Recurrence of Underlying Disease
Recurrence of the primary surgical pathology requiring additional medical or surgical treatment during follow-up.
Time frame: Within 12 months after surgery
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Meyer Children's Hospital IRCCS