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

NCT03274050 | Recruiting

• 2 other identifiers: NI16026J2017-A01507-46
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 1

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 and efficiency in a dedicated multidisciplinary pediatric program and to evaluate the relative cost of robotic surgery

Conditions

Surgery

Keywords

robot; surgery; pediatry (0-20 years included); adults

Outcome Measures

Primary Outcomes (1)

• Per and post-surgery complication

  per and post-surgery complication (Clavien-Dindo score)

  6 months

Secondary Outcomes (20)

• Post-surgery pain with analgesic prescription

  6 months

• Resection quality (R0) of oncologic surgery

  6 months

• Functional results according to the surgery indication

  6 months

• Quality of life (SF-36)

  6 months

• Health survey (EQ-5D-5L)

  6 months

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients operated in surgery department participating of the study with indication of robot in the routine care (all specialities)

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Intuitive Surgical: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker -Enfants Malades

Paris, Paris, 75015, France

RECRUITING

Related Publications (3)

• Franzini S, Querciagrossa S, Brebion M, Consonni D, Blanc T, Orliaguet G. Effect of retropneumoperitoneum on cerebral and renal oxygen saturation during retroperitoneal robotic-assisted laparoscopic pyeloplasty (R-RALP) in a pediatric population: Preliminary results of a prospective observational study using a dedicated anesthetic protocol and Near-InfraRed Spectroscopy. Anaesth Crit Care Pain Med. 2023 Oct;42(5):101234. doi: 10.1016/j.accpm.2023.101234. Epub 2023 Apr 28.

  PMID: 37121359 DERIVED

• Vinit N, Vatta F, Broch A, Hidalgo M, Kohaut J, Querciagrossa S, Couloigner V, Khen-Dunlop N, Botto N, Capito C, Sarnacki S, Blanc T. Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study. Ann Surg. 2023 Nov 1;278(5):e932-e938. doi: 10.1097/SLA.0000000000005808. Epub 2023 Jan 23.

  PMID: 36692109 DERIVED

• Harte C, Ren M, Querciagrossa S, Druot E, Vatta F, Sarnacki S, Dahmani S, Orliaguet G, Blanc T. Anaesthesia management during paediatric robotic surgery: preliminary results from a single centre multidisciplinary experience. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100837. doi: 10.1016/j.accpm.2021.100837. Epub 2021 Mar 20.

  PMID: 33757915 DERIVED

Study Officials

• Thomas BLANC, MD; PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Morgane ROUPRET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Thomas BLANC, MD, PhD

CONTACT

01 44 49 41 53; thomas.blanc@aphp.fr

Solimda SOTOU BERE

CONTACT

01 42 19 28 79; solimda.sotoubere@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: September 6, 2017
• Study Start: February 28, 2018
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)