Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Robotic Surgical Procedures. Базовые параметры: 0 Days — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Outcomes of Pediatric Robotic Surgery at a Tertiary Children's Hospital: A Retrospective Cohort Study
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Postoperative Complications Within 30 Days [Срок оценки: 30 days after surgery]
Вторичные конечные точки (5)
- Reintervention Rate [Срок оценки: 30 days after surgery]
- Hospital Readmission Rate [Срок оценки: 30 days after discharge]
- Postoperative Pain (VAS Score) [Срок оценки: 72 hours after surgery]
- Time to Resumption of Oral Feeding [Срок оценки: Within 48 hours after surgery]
- Recurrence of Underlying Disease [Срок оценки: Within 12 months after surgery]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Missing essential clinical or postoperative data required for analysis
- Documented opposition to the use of clinical data for research purposes
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07438704 · ROB-PED