Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-01-01 @ 8:46 AM
Study NCT ID:
NCT01300195
Status:
UNKNOWN
Last Update Posted:
2011-09-28
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood used to detect genetic polymorphism'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-27', 'studyFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent post surgical pain', 'timeFrame': '3 months', 'description': 'Pain intensity (Numerical Rating Scale)'}, {'measure': 'Analgesic use', 'timeFrame': '3 months', 'description': 'type(s) and amount of analgesics used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VATS', 'standardized surgery', 'persistent pain'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '23328340', 'type': 'DERIVED', 'citation': 'Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.'}]}, 'descriptionModule': {'briefSummary': 'Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 18 years old\n* Elective lung cancer surgery (VATS)\n\nExclusion Criteria:\n\n* do not understand Danish\n* cognitive reduction\n* bilateral procedure planned\n* previous thoracic surgery\n* pregnant or nursing\n* known nerve affection from other cause\n* alcohol/substance abuse\n* inability to cooperate to pain scoring/sensory examination\n* \\> 5 mg methylprednisolone/day'}, 'identificationModule': {'nctId': 'NCT01300195', 'briefTitle': 'Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Factors Predicting Persistent Post-surgical Pain After Video-assisted Thoracic Surgery (VATS)', 'orgStudyIdInfo': {'id': 'H4-2010-118#0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lung cancer surgery', 'description': 'Patients undergoing video-assisted thoracic surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kim Wildgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Ringsted, Md', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Section for Surgical Pathophysiology 4074', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Kim Wildgaard, MD', 'role': 'CONTACT', 'email': 'wildgaard@thoracotomy.eu', 'phone': '+45 3545 3246'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dept. of thoracic Surgery', 'class': 'AMBIG'}, {'name': 'Dept. of cardio-thoracic anaesthesia', 'class': 'AMBIG'}, {'name': 'Dept. Surgical PAthophysiology', 'class': 'AMBIG'}, {'name': 'all Blegdamsvej 9, 2100-Copenhagen, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'MD, Kim Wildgaard', 'oldOrganization': 'Section for Surgical Pathophysiology 4074'}}}}