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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Robotic Surgical Procedures

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Riccardo Coletta; Phone Number: 390555662499; Email: riccardo.coletta@meyer.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing robotic-assisted surgery at Meyer Children's Hospital IRCCS between January 2025 and December 2025.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric Robotic Surgery Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention Rate	Unplanned surgical reintervention within 30 days after the index robotic-assisted procedure.	30 days after surgery
Hospital Readmission Rate	Unplanned hospital readmission occurring within 30 days after discharge from the index hospitalization.	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.	72 hours after surgery
Time to Resumption of Oral Feeding	Time from surgery to resumption of oral feeding as documented in the medical record.	Within 48 hours after surgery
Recurrence of Underlying Disease	Recurrence of the primary surgical pathology requiring additional medical or surgical treatment during follow-up.	Within 12 months after surgery

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Robotic Surgical Procedures
• Other Study ID Numbers: ROB-PED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No