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Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital

Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital: A Retrospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07438704
Acronym
ROB-PED
Enrollment
100
Registered
2026-02-27
Start date
2026-03-01
Completion date
2026-12-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robotic Surgical Procedures

Keywords

Robotic Surgical Procedures

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age \< 18 years at the time of surgery * Underwent robotic-assisted surgical procedure (digestive, urologic, gynecologic, or thoracic surgery) * Surgery performed between January 2025 and December 2025 at Meyer Children's Hospital IRCCS * Availability of essential clinical and perioperative data in the medical record

Exclusion criteria

* Missing essential clinical or postoperative data required for analysis * Documented opposition to the use of clinical data for research purposes

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Complications Within 30 Days30 days after surgeryOccurrence 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.

Secondary

MeasureTime frameDescription
Reintervention Rate30 days after surgeryUnplanned surgical reintervention within 30 days after the index robotic-assisted procedure.
Hospital Readmission Rate30 days after dischargeUnplanned hospital readmission occurring within 30 days after discharge from the index hospitalization.
Postoperative Pain (VAS Score)72 hours after surgeryPain intensity measured using the Visual Analog Scale (VAS) every 6 hours during the first 72 postoperative hours, as recorded in routine clinical documentation.
Time to Resumption of Oral FeedingWithin 48 hours after surgeryTime from surgery to resumption of oral feeding as documented in the medical record.
Recurrence of Underlying DiseaseWithin 12 months after surgeryRecurrence of the primary surgical pathology requiring additional medical or surgical treatment during follow-up.

Contacts

CONTACTRiccardo Coletta
riccardo.coletta@meyer.it390555662499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026