Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:05 AM
Study NCT ID:
NCT07438704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Complications Within 30 Days', 'timeFrame': '30 days after surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Reintervention Rate', 'timeFrame': '30 days after surgery', 'description': 'Unplanned surgical reintervention within 30 days after the index robotic-assisted procedure.'}, {'measure': 'Hospital Readmission Rate', 'timeFrame': '30 days after discharge', 'description': 'Unplanned hospital readmission occurring within 30 days after discharge from the index hospitalization.'}, {'measure': 'Postoperative Pain (VAS Score)', 'timeFrame': '72 hours after surgery', 'description': 'Pain intensity measured using the Visual Analog Scale (VAS) every 6 hours during the first 72 postoperative hours, as recorded in routine clinical documentation.'}, {'measure': 'Time to Resumption of Oral Feeding', 'timeFrame': 'Within 48 hours after surgery', 'description': 'Time from surgery to resumption of oral feeding as documented in the medical record.'}, {'measure': 'Recurrence of Underlying Disease', 'timeFrame': 'Within 12 months after surgery', 'description': 'Recurrence of the primary surgical pathology requiring additional medical or surgical treatment during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic Surgical Procedures'], 'conditions': ['Robotic Surgical Procedures']}, 'descriptionModule': {'briefSummary': "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.\n\nAll 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.\n\nThe 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.\n\nData will be collected retrospectively from electronic medical records, operative registries, laboratory reports, and follow-up documentation up to 12 months after surgery.", 'detailedDescription': "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.\n\nThis 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.\n\nClinical 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.\n\nThe primary outcome is the occurrence of postoperative complications within 30 days, classified according to the Clavien-Dindo grading system when applicable.\n\nSecondary outcomes include:\n\nConversion from robotic to open surgery\n\nReintervention within 30 days\n\nReadmission within 30 days\n\nSurgical site and nosocomial infections\n\nPostoperative length of stay\n\nPostoperative pain assessed by Visual Analog Scale (VAS) within the first 72 hours\n\nTime to resumption of oral feeding and bowel function\n\nRecurrence of the primary surgical condition within 12 months\n\nAdditionally, 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.\n\nData will be analyzed using appropriate descriptive and comparative statistical methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pediatric patients undergoing robotic-assisted surgery at Meyer Children's Hospital IRCCS between January 2025 and December 2025.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\< 18 years at the time of surgery\n* Underwent robotic-assisted surgical procedure (digestive, urologic, gynecologic, or thoracic surgery)\n* Surgery performed between January 2025 and December 2025 at Meyer Children's Hospital IRCCS\n* Availability of essential clinical and perioperative data in the medical record\n\nExclusion Criteria:\n\n* Missing essential clinical or postoperative data required for analysis\n* Documented opposition to the use of clinical data for research purposes"}, 'identificationModule': {'nctId': 'NCT07438704', 'acronym': 'ROB-PED', 'briefTitle': "Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital", 'organization': {'class': 'OTHER', 'fullName': "Meyer Children's Hospital IRCCS"}, 'officialTitle': "Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital: A Retrospective Cohort Study", 'orgStudyIdInfo': {'id': 'ROB-PED'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Riccardo Coletta', 'role': 'CONTACT', 'email': 'riccardo.coletta@meyer.it', 'phone': '390555662499'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Meyer Children's Hospital IRCCS", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MEDICAL DOCTOR', 'investigatorFullName': 'Riccardo Coletta', 'investigatorAffiliation': "Meyer Children's Hospital IRCCS"}}}}