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

ConditionSurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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, effectiveness, and cost-effectiveness of robot-assisted minimally invasive surgery in both pediatric and adult patients. Robotic surgery was developed to overcome key limitations of conventional laparoscopy, including 2D visualization, limited instrument mobility, poor ergonomics, and long learning curves. The trial will assess clinical outcomes, postoperative pain, length of stay, return to daily activities, access to minimally invasive surgery, and the impact of robotic surgery on surgical training. Specific indications, such as pyeloplasty, will also be compared with open and conventional laparoscopic approaches.

Eligibility criteria

Qualifiers

child or adult

with an indication for a robotic surgery

non-opposition of patient or non-opposition of parents for minor patient

Disqualifiers

anatomic or anesthetic contraindication for the mini-invasive surgery

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

16,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Intuitive Surgical

Collaborator

URC-CIC Paris Descartes Necker Cochin

Collaborator