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NCT Number: NCT07438704

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

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.

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Key information

Age range

0 day–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative Complications Within 30 Days

    Time frame: 30 days after surgery

    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.

Secondary outcomes

  1. Reintervention Rate

    Time frame: 30 days after surgery

    Unplanned surgical reintervention within 30 days after the index robotic-assisted procedure.

  2. Hospital Readmission Rate

    Time frame: 30 days after discharge

    Unplanned hospital readmission occurring within 30 days after discharge from the index hospitalization.

  3. Postoperative Pain (VAS Score)

    Time frame: 72 hours after surgery

    Pain intensity measured using the Visual Analog Scale (VAS) every 6 hours during the first 72 postoperative hours, as recorded in routine clinical documentation.

  4. Time to Resumption of Oral Feeding

    Time frame: Within 48 hours after surgery

    Time from surgery to resumption of oral feeding as documented in the medical record.

  5. Recurrence of Underlying Disease

    Time frame: Within 12 months after surgery

    Recurrence of the primary surgical pathology requiring additional medical or surgical treatment during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Riccardo Coletta

CONTACT

[email protected]

390555662499

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Acronym: ROB-PED

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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