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

Recruiting now

Conditions studied: Surgery

In brief

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.

Key facts

Study ID

NCT03274050

Run by

Assistance Publique - Hôpitaux de Paris

People needed

16000

Starts

2018-02-28

Expected to finish

2029-08-01

Last updated by the study team

2026-08-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• child or adult
• with an indication for a robotic surgery
• non-opposition of patient or non-opposition of parents for minor patient

You may not qualify if…

• anatomic or anesthetic contraindication for the mini-invasive surgery

Where it is running

• Hôpital Necker -Enfants Malades — Paris, Paris, France (enrolling)

Full record on ClinicalTrials.gov

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