Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT05732857
Status:
UNKNOWN
Last Update Posted:
2023-02-17
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight', 'timeFrame': 'before extubation'}], 'secondaryOutcomes': [{'measure': 'postoperative acute pain: using the NRS scale', 'timeFrame': 'at 1 hour and at 4 hour after the end of surgery'}, {'measure': 'subcutaneous emphysema: through clinical observation at the end of the intervention', 'timeFrame': 'at 30 minutes afetr the end of anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robotic nephrectomy', 'pneumoperitoneum', 'trocar valveless', 'general anesthesia', 'mechanical ventilation'], 'conditions': ['Cancer of Kidney']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.', 'detailedDescription': 'In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asa status 1-3\n* surgical classification RENAL or PADUA score \\>9\n\nExclusion Criteria:\n\n* BMI\\>30'}, 'identificationModule': {'nctId': 'NCT05732857', 'briefTitle': 'Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study', 'orgStudyIdInfo': {'id': '1795/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'trocar standard', 'description': 'patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery', 'interventionNames': ['Device: standard trocar']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'trocar valveless', 'description': 'patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery', 'interventionNames': ['Device: valveless trocar']}], 'interventions': [{'name': 'valveless trocar', 'type': 'DEVICE', 'otherNames': ['airseal'], 'description': 'the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen', 'armGroupLabels': ['trocar valveless']}, {'name': 'standard trocar', 'type': 'DEVICE', 'description': 'standard trocar, usually camera port for robotic surgery', 'armGroupLabels': ['trocar standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ester Forastiere, MD', 'role': 'CONTACT', 'email': 'forastiere@ifo.it', 'phone': '0652662942', 'phoneExt': '+ 39'}, {'name': 'Maria Sofra, MD', 'role': 'CONTACT', 'email': 'sofra@ifo.it', 'phone': '0652662942', 'phoneExt': '+ 39'}, {'name': 'Marco Covotta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'E Forastiere, MD, Head of Anestesiology and Intensive care Unit', 'investigatorFullName': 'Ester Forastiere, MD', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}