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RECRUITING
NCT03274050

To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical procedures in adult patients across a broad spectrum of surgical specialties. This has occurred despite the high costs and uncertain benefits of surgical robots. In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to embrace the surgical robot. Many children's hospitals do not even possess a surgical robot, and many of those that do borrow them from the adult operating room within the same medical facility. Since the first case of robotic minimally invasive surgery in children in 2000, robotic procedures have been slowly adopted by select pediatric surgical specialists. Advocates of robotic minimally invasive surgical systems add many useful features that include improved dexterity, motion scaling, tremor filtration, greater optical magnification (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic instruments used in robotic surgery provide seven degrees of freedom. For the surgeon, these features may allow for more precise dissection with increased magnification and visibility. The intuitive controls of the robot are purported as providing the ability to perform laparoscopic procedures in an "open" fashion. In pediatric surgical procedures, these technical abilities may have the potential to surpass the physical capabilities of human performance in the tight operative fields encountered in children. This study aims to evaluate the clinical safety and efficiency in a dedicated multidisciplinary pediatric program and to evaluate the relative cost of robotic surgery

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

16000

Start Date

2018-02-28

Completion Date

2029-08

Last Updated

2025-11-20

Healthy Volunteers

No

Conditions

Locations (1)

Hôpital Necker -Enfants Malades

Paris, Paris, France