Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07099105
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subcostal Single-port Versus Intercostal Multi-port Robotic Lobectomy for Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 339}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Postoperatively day 0,1,2,3', 'description': 'Postoperative pain using visual analog scale (minimum =0, maximum=10), A lower value reflects a lesser degree of pain perception (lower scores mean a better outcome)'}], 'secondaryOutcomes': [{'measure': 'chest tube duration', 'timeFrame': 'Perioperative', 'description': 'Chest tube duration refers to the number of days a thoracic drain remains in situ following pulmonary surgery. The duration is measured in days (minimum: 1, maximum: no defined). Lower scores indicate a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38678475', 'type': 'BACKGROUND', 'citation': 'Lee JH, Park TH, Kim HK. Robotic thoracic surgery using the single-port robotic system: Initial experience with more than 100 cases. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1513-1522.e2. doi: 10.1016/j.jtcvs.2024.03.005. Epub 2024 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is compared the perioperative outcomes of robotic lobectomy using the SP system via the subcostal approach with those of multi-port robotic lobectomy using the Xi system via the intercostal approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged \\> 18 years who underwent robotic lobectomy for non-small cell lung cancer at the Korea University Guro Hospital between January 2017 and December 2024. Patients were categorized into the SP and MP groups based on the surgical approach employed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged \\> 18 years who underwent RATS lobectomy for NSCLC at the Korea University Guro Hospital between January 2017 and December 2024\n\nExclusion Criteria:\n\n* patients who underwent Viedo-assisted thoracic surgery lobectomy\n* patients who underwent robotic lobectomy with other combined surgery\n* patients who received neoadjuvant therapy'}, 'identificationModule': {'nctId': 'NCT07099105', 'acronym': 'SP vs MP robot', 'briefTitle': 'Subcostal Single-port Versus Intercostal Multi-port Robotic Lobectomy for Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Subcostal Single-port Versus Intercostal Multi-port Robotic Lobectomy for Non-small Cell Lung Cancer: A Single-centre Retrospective Propensity Matched Study', 'orgStudyIdInfo': {'id': '2025GR0224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SP group', 'description': 'Patients with non-small cell lung cancer who underwent single-port robotic lobectomy. All procedures were performed using the SP system via the subcostal approach.'}, {'label': 'MP', 'description': 'Patients with non-small cell lung cancer who underwent multi-port robotic lobectomy. All procedures were performed using the Xi system via the intercostal approach.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyun Koo Kim', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}