Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT03240250
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study on Effects of Uniportal VATS Versus Triportal VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of postoperative pain after uni-portal and three-portal VATS', 'timeFrame': '7 days', 'description': 'Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.'}], 'secondaryOutcomes': [{'measure': 'Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.', 'timeFrame': '30 days', 'description': 'A pain score will be assigned to each patient after the total amount of NRS'}, {'measure': 'Valuation of respiratory function', 'timeFrame': '30 days', 'description': 'Spirometry after 7 and 30 days from surgery, compared with pre-operative tests'}, {'measure': 'Intraoperative parameters', 'timeFrame': '1 day', 'description': 'Operative time (skin to skin, minutes)'}, {'measure': 'Intraoperative bleeding', 'timeFrame': '1 day', 'description': 'Amount of bleeding'}, {'measure': 'Postoperative air leakage', 'timeFrame': '15 days', 'description': 'Rate of prolonged air leaks'}, {'measure': 'Postoperative complications', 'timeFrame': '1 month', 'description': 'Cardiac rythhm disfunctions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VATS', 'Pulmonary lobectomy', 'Uniportal', 'Postoperative pain', 'Thoracic surgery'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '33632284', 'type': 'DERIVED', 'citation': 'Mendogni P, Mazzucco A, Palleschi A, Rosso L, Righi I, Carrinola R, Damarco F, Privitera E, Fumagalli J, Bonitta G, Nosotti M, Tosi D. Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial. Trials. 2021 Feb 25;22(1):163. doi: 10.1186/s13063-021-05115-w.'}]}, 'descriptionModule': {'briefSummary': 'For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective.\n\nThe main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain.\n\nSecondary objectives of the study are valutations of:\n\n* respiratory and functional capacity between the two groups\n* operative time\n* number of resected lymphnodes\n* intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.', 'detailedDescription': 'Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique\n\nArm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach\n\nArm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach\n\nMisurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.\n\nThe choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability.\n\nSecondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS.\n\nRespiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests.\n\nAll intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding.\n\nPostoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clinical diagnosis of NSCLC, stage I-II, age 30-75, who undergo pulmonary lobectomy and limphadenectomy with radical intent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm\n* ASA (American Society of Anestesiology) score 1-2-3\n\nExclusion Criteria:\n\n* N2-N3 disease\n* Induction chemotherapy\n* Thoracic wall infiltration\n* Previous thoracic surgery\n* Important pleural adhesions\n* Severe COPD, asthma, interstitial lung disease - Liver, kidney or cardiac failure\n* Clotting disorders\n* Analgesic allergy\n* Sublobar resection, sleeve lobectomy, pneumonectomy\n* Chronic analgesic, oppioids or cortisonic use\n* Absence of informed consent'}, 'identificationModule': {'nctId': 'NCT03240250', 'briefTitle': 'Randomized Study on Effects of Uniportal VATS Versus Triportal VATS', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC', 'orgStudyIdInfo': {'id': '3564'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uni-portal VATS', 'description': 'VATS uni-portal lobectomy and lymphoadenectomy', 'interventionNames': ['Procedure: VATS uni-portal lobectomy and lymphoadenectomy']}, {'label': 'Three-portal VATS', 'description': 'VATS three-portal lobectomy and lymphoadenectomy', 'interventionNames': ['Procedure: VATS three-portal lobectomy and lymphoadenectomy']}], 'interventions': [{'name': 'VATS uni-portal lobectomy and lymphoadenectomy', 'type': 'PROCEDURE', 'description': 'VATS uni-portal lobectomy and lymphoadenectomy', 'armGroupLabels': ['Uni-portal VATS']}, {'name': 'VATS three-portal lobectomy and lymphoadenectomy', 'type': 'PROCEDURE', 'description': 'VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach', 'armGroupLabels': ['Three-portal VATS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Milan', 'state': 'Mi', 'country': 'Italy', 'facility': "Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Davide Tosi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione Ca' Granda IRCCS Policlinico Milan"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}