Robotic Surgical ProceduresROB-PEDNCT07438704
Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital
An observational study of Robotic Surgical Procedures, run by Meyer Children's Hospital IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Robotic Surgical Procedures
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing robotic-assisted surgery at Meyer Children's Hospital IRCCS between January 2025 and December 2025.
Who may be able to join
- 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
Who cannot join
- Missing essential clinical or postoperative data required for analysis
- Documented opposition to the use of clinical data for research purposes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Robotic Surgical Procedures
- Keywords
- Robotic Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after surgery
Secondary outcomes (5)
Reintervention Rate
Unplanned surgical reintervention within 30 days after the index robotic-assisted procedure.
Measured: 30 days after surgery
Hospital Readmission Rate
Unplanned hospital readmission occurring within 30 days after discharge from the index hospitalization.
Measured: 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.
Measured: 72 hours after surgery
Time to Resumption of Oral Feeding
Time from surgery to resumption of oral feeding as documented in the medical record.
Measured: Within 48 hours after surgery
Recurrence of Underlying Disease
Recurrence of the primary surgical pathology requiring additional medical or surgical treatment during follow-up.
Measured: Within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Coletta, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438704
- Sponsor's protocol ID
- ROB-PED
- Acronym
- ROB-PED
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07438704
- Acronym / sponsor ID
- ROB-PED / ROB-PED
- Conditions
- Robotic Surgical Procedures
- Keywords
- Robotic Surgical Procedures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing robotic-assisted surgery at Meyer Children's Hospital IRCCS between January 2025 and December 2025.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Missing essential clinical or postoperative data required for analysis
- Documented opposition to the use of clinical data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Reintervention Rate
Time frame: 30 days after surgery
Hospital Readmission Rate
Time frame: 30 days after discharge
Postoperative Pain (VAS Score)
Time frame: 72 hours after surgery
Time to Resumption of Oral Feeding
Time frame: Within 48 hours after surgery
Recurrence of Underlying Disease
Time frame: Within 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgical Procedures, run by Meyer Children's Hospital IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Coletta (390555662499, riccardo.coletta@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications Within 30 Days (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.