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

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• child or adult

• with an indication for a robotic surgery

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

Locations
Other Locations
France
Hôpital Necker -Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Thomas BLANC, MD, PhD
thomas.blanc@aphp.fr
01 44 49 41 53
Backup
Solimda SOTOU BERE
solimda.sotoubere@aphp.fr
01 42 19 28 79
Time Frame
Start Date: 2018-02-28
Estimated Completion Date: 2029-08
Participants
Target number of participants: 16000
Treatments
patient group
Surgery with robot - all patients operated in surgery department with indication of robot in the routine care (all specialities).
control group
Retroperitoneal coelioscopy - patient operated for pyeloplasty - only for pediatry
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris
Collaborators: Intuitive Surgical

This content was sourced from clinicaltrials.gov

Similar Clinical Trials