Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT03274050
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-09-04', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Per and post-surgery complication', 'timeFrame': '6 months', 'description': 'per and post-surgery complication (Clavien-Dindo score)'}], 'secondaryOutcomes': [{'measure': 'Post-surgery pain with analgesic prescription', 'timeFrame': '6 months'}, {'measure': 'Resection quality (R0) of oncologic surgery', 'timeFrame': '6 months'}, {'measure': 'Functional results according to the surgery indication', 'timeFrame': '6 months'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': '6 months', 'description': '36-items Short Form health survey'}, {'measure': 'Health survey (EQ-5D-5L)', 'timeFrame': '6 months', 'description': 'Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5)'}, {'measure': "The Saint-George's hospital Respiratory Questionnaire (SGRQ)", 'timeFrame': '6 months', 'description': '0 indicates best health and 100 indicates worst health'}, {'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': '6 months', 'description': "1-question assessment designed to evaluate the patient's impression of improvement since surgery- PGI-I score: 1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 6 = much worse; 7 = very much worse"}, {'measure': 'Frequency and percentage of intervention with robot in each speciality', 'timeFrame': '6 months'}, {'measure': 'Duration of activity of the operating block', 'timeFrame': '6 months'}, {'measure': 'Average duration of anaesthesia', 'timeFrame': '6 months'}, {'measure': 'Average duration of robotic surgery and docking', 'timeFrame': '6 months'}, {'measure': 'Duration of intervention by speciality (learning curve)', 'timeFrame': '6 months'}, {'measure': 'Frequency and percentage of conversion to open-procedure', 'timeFrame': '6 months'}, {'measure': 'Post surgery pain (Evendol pain scale)', 'timeFrame': '6 months'}, {'measure': 'Prescription of analgesic', 'timeFrame': '6 months'}, {'measure': 'Duration of hospitalization', 'timeFrame': '6 months'}, {'measure': 'Cost of robotic surgery by indication, tools and supplies', 'timeFrame': '6 months'}, {'measure': 'Duration of post surgery work stoppage (activ patient)', 'timeFrame': '6 months'}, {'measure': 'Duration before returning to normal activity (other patient)', 'timeFrame': '6 months'}, {'measure': 'Difference in average costs per patients (in €) divided by the difference in post operative complications using the Clavien Dindo scale', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robot', 'surgery', 'pediatry (0-20 years included)', 'adults'], 'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '37121359', 'type': 'DERIVED', 'citation': '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': '36692109', 'type': 'DERIVED', 'citation': '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': '33757915', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nSince the first case of robotic minimally invasive surgery in children in 2000, robotic procedures have been slowly adopted by select pediatric surgical specialists.\n\nAdvocates 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.\n\nFor 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.\n\nThis study aims to evaluate the clinical safety and efficiency in a dedicated multidisciplinary pediatric program and to evaluate the relative cost of robotic surgery', 'detailedDescription': 'Laparoscopy has been adopted for advantages that include decreased adhesion formation, improved cosmesis, decreased post-operative pain, and shorter recovery times.\n\nThe patient benefits of robotic surgery are thought to be essentially the same as conventional laparoscopy: decreased length of stay, decreased blood loss, decreased pain, quicker return to work, and improved cosmetic result through smaller incisions. In pediatric urology, there is evidence that robot-assisted pyeloplasty may be superior to open and laparoscopic approach with decreased length of stay, decreased narcotic use, and decreased operative times.\n\nThe overall reported conversion-to-open-procedure rate is low, comparable to the conversion rate in conventional pediatric minimally invasive surgery.\n\nRobotic surgical technology may have a role in pediatric minimal access surgery. Design features of robotic surgical platforms include motion scaling, greater optical magnification, stereoscopic vision, increased instrument tip dexterity, tremor filtration, instrument indexing, operator controlled camera movement, and elimination of the fulcrum effect. These robotic enhancements offer improvements to conventional minimal access surgery, permitting technical capabilities beyond existing threshold limits of human performance for surgery within the spatially constrained operative workspaces in children. There is evidence that a learning curve is encountered when adopting robotic surgery as demonstrated by decreasing operative times as case volumes increased\n\nAt a stand-alone pediatric hospital, a robotic platform is often not available. Only a minority of pediatric hospitals have robotic systems given the limited number of procedures performed nationally. This is probably due to the costs of acquiring and maintaining a surgical robot coupled with the tendency for pediatric hospitals to have less income and fewer eligible patients to defray the fixed costs of the platform. A unique situation exists for pediatric surgeons in hospitals affiliated with adult care as robots may be available that are primarily used for adult subspecialties, most often urology. In this setup, the logistics may be difficult and the pediatric team must be flexible and mobile to accommodate the robot.\n\nRobotic surgery has higher costs than open and laparoscopic procedures. This is due to the high costs of purchasing and maintaining a robot, increased operative time, and costs of disposable surgical supplies.\n\nThe specificity of this study is to evaluate the clinical safety and efficiency in a dedicated multidisciplinary pediatric program (gastrointestinal surgery, genitourinary surgery, thoracic surgery, ENT, cardiac surgery and microsurgery) and to evaluate the relative cost of robotic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients operated in surgery department participating of the study with indication of robot in the routine care (all specialities)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* child or adult\n* with an indication for a robotic surgery\n* non-opposition of patient or non-opposition of parents for minor patient\n\nExclusion Criteria :\n\n* anatomic or anesthetic contraindication for the mini-invasive surgery'}, 'identificationModule': {'nctId': 'NCT03274050', 'acronym': 'PECRoP', 'briefTitle': 'To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults', 'orgStudyIdInfo': {'id': 'NI16026J'}, 'secondaryIdInfos': [{'id': '2017-A01507-46', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient group', 'description': 'Surgery with robot - all patients operated in surgery department with indication of robot in the routine care (all specialities).'}, {'label': 'control group', 'description': 'Retroperitoneal coelioscopy - patient operated for pyeloplasty - only for pediatry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Blanc, MD, PhD', 'role': 'CONTACT', 'email': 'thomas.blanc@aphp.fr', 'phone': '01 44 49 41 53'}], 'facility': 'Hôpital Necker -Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Thomas BLANC, MD, PhD', 'role': 'CONTACT', 'email': 'thomas.blanc@aphp.fr', 'phone': '01 44 49 41 53'}, {'name': 'Solimda SOTOU BERE', 'role': 'CONTACT', 'email': 'solimda.sotoubere@aphp.fr', 'phone': '01 42 19 28 79'}], 'overallOfficials': [{'name': 'Thomas BLANC, MD; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Morgane ROUPRET, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}