Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital (ROB-PED)

Meyer Children's Hospital IRCCS

Status: Not yet enrolling

Conditions: Robotic Surgical Procedures

Study type: Observational

Funder types: Other

Identifiers

NCT07438704

ROB-PED

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Pediatric Robotic Surgery Cohort

Description:

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.