Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT06118593
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Why in Hospital After Wedge Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Up to the day of discharge', 'description': 'Number of overnight stay'}, {'measure': 'Reasons for staying in hospital', 'timeFrame': 'Up to the day of discharge', 'description': 'patient-reported outcomes for why in hospital, including pain or social factors; postoperative complications, diagnosed by clinicians'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain scale', 'timeFrame': 'At the day of surgery', 'description': 'The pain scale (from 0 to 10) will be evaluated by patients.'}, {'measure': 'Duration of chest drain', 'timeFrame': 'Up to the day of chest drain removed', 'description': 'Days of chest drain placed'}, {'measure': 'Postoperative complications', 'timeFrame': 'Up to postoperative day 30', 'description': 'Diagonosis is following ICD-10'}, {'measure': '30-day readmissions', 'timeFrame': 'Up to postoperative day 30', 'description': 'Admission to hospital again within 30 days after surgery'}, {'measure': 'Postoperative activity', 'timeFrame': 'At the day of surgery', 'description': 'Patients report whether they can stand up, walk within 6 meters, or walk over 6 meters, up to 3 and 6 hours after surgery'}, {'measure': 'Opioid usage', 'timeFrame': 'At the day of surgery and at the day of discharge', 'description': 'It is classified as opioid used and no opioid used'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Surgery, Video-Assisted', 'Enhanced Recovery After Surgery']}, 'referencesModule': {'references': [{'pmid': '39374548', 'type': 'DERIVED', 'citation': 'Huang L, Kehlet H, Petersen RH. Why do patients stay in hospital after enhanced recovery thoracoscopic wedge resection? A prospective observational study. Eur J Cardiothorac Surg. 2024 Oct 1;66(4):ezae366. doi: 10.1093/ejcts/ezae366.'}]}, 'descriptionModule': {'briefSummary': 'In the realm of lung surgery, video-assisted thoracoscopic surgery (VATS) offers distinct advantages, including shorter hospital stays, reduced pain, improved quality of life, and increased postoperative mobility when compared to thoracotomy. Additionally, the enhanced recovery after surgery (ERAS) protocol in lung surgery, characterized by a comprehensive, multidisciplinary approach, have streamlined postoperative recovery, resulting in early discharge and diminished postoperative complications. However, drawing from our extensive experience with fully implemented ERAS VATS for patients undergoing pulmonary lobectomy, we observed that approximately 45% of patients did not experience early discharge.\n\nBased on existing evidence, the length of stay (LOS) following wedge resection typically ranges from 3 to 6 days across various regions, including Europe, the United States, and China. However, there is a notable lack of procedure-specific data for ERAS VATS wedge resection to explore reasons of delaying discharge. This prompts us to undertake an investigation into individuals following pulmonary wedge resection under the same ERAS programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent video-assisted thoracoscopic surgery wedge resection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent video-assisted thoracoscopic surgery wedge resection\n\nExclusion Criteria:\n\n* \\< 18 year old\n* Unable to understand Danish\n* No residence in the Eastern Denmark\n* Transfer to anatomical resection or cancel surgery\n* Reject to join or withdraw from the study'}, 'identificationModule': {'nctId': 'NCT06118593', 'briefTitle': 'Why in Hospital After Wedge Resection', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Why in Hospital After ERAS VATS Wedge Resection', 'orgStudyIdInfo': {'id': 'P-2022-238'}}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'René H Petersen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data is possible shared to other researchers if they contact with study director and the approvals are obtained subsequently.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Cardiothoracic Surgery', 'investigatorFullName': 'Lin Huang', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}