NCT03274050 To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults
| NCT ID | NCT03274050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 16,000 participants |
| Start Date | 2018-02-28 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16,000 participants in total. It began in 2018-02-28 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 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
Inclusion Criteria : * child or adult * with an indication for a robotic surgery * non-opposition of patient or non-opposition of parents for minor patient Exclusion Criteria : * anatomic or anesthetic contraindication for the mini-invasive surgery
Contact & Investigator
Thomas BLANC, MD; PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT03274050 clinical trial?
This trial is open to participants of all sexes, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03274050 currently recruiting?
Yes, NCT03274050 is actively recruiting participants. Contact the research team at thomas.blanc@aphp.fr for enrollment information.
Where is the NCT03274050 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT03274050 clinical trial?
NCT03274050 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Thomas BLANC, MD; PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 16,000 participants.