NCT07438704

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 23, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

Robotic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Reintervention Rate

    30 days after surgery

  • Hospital Readmission Rate

    30 days after discharge

  • Postoperative Pain (VAS Score)

    72 hours after surgery

  • Time to Resumption of Oral Feeding

    Within 48 hours after surgery

  • Recurrence of Underlying Disease

    Within 12 months after surgery

Study Arms (1)

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.

Eligibility Criteria

Age0 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEDICAL DOCTOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02