Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT01104233
Status:
UNKNOWN
Last Update Posted:
2010-04-15
First Post:
2010-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-13', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the level of postoperative pain between the rigid and soft spreading groups', 'timeFrame': '1 day', 'description': 'The level of postoperative pain was measured by Visual Analogue Scale (VAS).'}], 'secondaryOutcomes': [{'measure': 'Compare early postoperative analgesic requirements between the rigid and soft spreading groups', 'timeFrame': '1 week', 'description': 'Postoperative analgesic requirements (e.g. the amount of morphine titration).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Video-assisted Thoracoscopic Surgery', 'Soft spreading', 'LAP Protector'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if different types of spreading (rigid or soft) of Video-assisted Thoracoscopic Surgery (VATS) for lung cancer have different effects on pain.', 'detailedDescription': 'The Lap-Protector (Hakko Co., Japan) is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings. If the two rings are pulled apart, the device assumes a cylindrical shape. The outer diameter of each flexible ring is 12 cm, and this device can be used for minilaparotomy wounds between 5 and 9cm long.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-small cell lung cancer stage IB - IIIA\n* ECOG status 0-1\n\nExclusion Criteria:\n\n* Prior chemotherapy and/or radiation therapy for lung cancer\n* Peripheral neuropathy \\> grade 1\n* Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n* Medical condition that will not permit treatment or follow up according to the protocol\n* Pregnant or nursing women\n* HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT01104233', 'briefTitle': 'Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)', 'orgStudyIdInfo': {'id': 'FAHG20100320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The soft spreading', 'description': 'Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector).', 'interventionNames': ['Device: LAP Protector']}, {'label': 'The rigid spreading', 'description': 'Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading.'}], 'interventions': [{'name': 'LAP Protector', 'type': 'DEVICE', 'description': 'The LAP Protector is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings', 'armGroupLabels': ['The soft spreading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqiang Yin, MD', 'role': 'CONTACT', 'email': 'yinwq88@21cn.com', 'phone': '+86-20-83337792'}, {'name': 'Daoyuan Wang, MD', 'role': 'CONTACT', 'email': 'ghealth2008@gmail.com', 'phone': '+86-20-83337792'}, {'name': 'Jianxing He, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical College', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xin Xu, MD', 'role': 'CONTACT', 'email': 'yichunrenjia@126.com', 'phone': '+86-20-83337792'}, {'name': 'Wenlong Shao, MD', 'role': 'CONTACT', 'email': 'myfriends2003@126.com', 'phone': '+86-20-83337792'}], 'overallOfficials': [{'name': 'Jianxing He, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'The First Affiliated Hospital of Guangzhou Medical College', 'oldOrganization': 'Guangzhou Medical College'}}}}