Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT05358158
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2022-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Pain', 'timeFrame': 'Up to postoperative day 1', 'description': 'Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m'}, {'measure': 'Rescue analgesics', 'timeFrame': 'Up to postoperative day 1', 'description': 'The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry'}], 'secondaryOutcomes': [{'measure': 'Pneumothorax', 'timeFrame': 'Up to postoperative 2 weeks', 'description': 'Number and size of pneumothorax at 6 hours after surgery in the drain-free group, 2 hours after drain removal in the drain group, and postoperative 2-week for both'}, {'measure': 'Complications', 'timeFrame': 'Up to postoperative day 30', 'description': 'Surgical and medical complications including mortality'}, {'measure': 'Chest drain reinsertion', 'timeFrame': 'Up to postoperative day 30', 'description': 'Number and reasons of chest drain reinsertion'}, {'measure': 'Length of stay', 'timeFrame': 'Through post-operative discharge, an average of 2 days', 'description': 'Days in hospital after index surgery'}, {'measure': 'Time to fulfilled discharge criteria', 'timeFrame': 'Through post-operative discharge, an average of 2 days', 'description': 'Days to meet discharge criteria but stay in hospital'}, {'measure': 'Readmission', 'timeFrame': 'Through post-operative admission, an average of 7 days', 'description': 'Number and reasons of readmissions'}, {'measure': 'Quality of recovery after surgery', 'timeFrame': 'Up to postoperative day 1', 'description': "Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery"}, {'measure': 'Standard analgesics given', 'timeFrame': 'Up to postoperative 2 weeks', 'description': 'Number of patients who did not receive planned postoperative analgesics according to the standards at their institution'}, {'measure': 'Persistent pain', 'timeFrame': 'Up to postoperative day 6', 'description': 'Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Neoplasms', 'Lung Surgery', 'Enhanced Recovery After Surgery', 'Fast-track Surgery', 'Pain', 'Opioid Use', 'Remission']}, 'referencesModule': {'references': [{'pmid': '20619231', 'type': 'RESULT', 'citation': 'Cerfolio RJ, Bryant AS. The management of chest tubes after pulmonary resection. Thorac Surg Clin. 2010 Aug;20(3):399-405. doi: 10.1016/j.thorsurg.2010.04.001.'}, {'pmid': '17588421', 'type': 'RESULT', 'citation': "Luckraz H, Rammohan KS, Phillips M, Abel R, Karthikeyan S, Kulatilake NE, O'Keefe PA. Is an intercostal chest drain necessary after video-assisted thoracoscopic (VATS) lung biopsy? Ann Thorac Surg. 2007 Jul;84(1):237-9. doi: 10.1016/j.athoracsur.2007.03.007."}, {'pmid': '26514281', 'type': 'RESULT', 'citation': 'Holbek BL, Horsleben Petersen R, Kehlet H, Hansen HJ. Fast-track video-assisted thoracoscopic surgery: future challenges. Scand Cardiovasc J. 2016;50(2):78-82. doi: 10.3109/14017431.2015.1114665. Epub 2015 Dec 1.'}, {'pmid': '22219425', 'type': 'RESULT', 'citation': 'Refai M, Brunelli A, Salati M, Xiume F, Pompili C, Sabbatini A. The impact of chest tube removal on pain and pulmonary function after pulmonary resection. Eur J Cardiothorac Surg. 2012 Apr;41(4):820-2; discussion 823. doi: 10.1093/ejcts/ezr126. Epub 2011 Dec 21.'}, {'pmid': '26016583', 'type': 'RESULT', 'citation': 'Mao M, Hughes R, Papadimos TJ, Stawicki SP. Complications of chest tubes: a focused clinical synopsis. Curr Opin Pulm Med. 2015 Jul;21(4):376-86. doi: 10.1097/MCP.0000000000000169.'}, {'pmid': '12693389', 'type': 'RESULT', 'citation': 'Bardell T, Petsikas D. What keeps postpulmonary resection patients in hospital? Can Respir J. 2003 Mar;10(2):86-9. doi: 10.1155/2003/610570.'}, {'pmid': '22219442', 'type': 'RESULT', 'citation': 'Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.'}, {'pmid': '15082297', 'type': 'RESULT', 'citation': 'Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.'}, {'pmid': '20308263', 'type': 'RESULT', 'citation': 'Koc T, Routledge T, Chambers A, Scarci M. Do patients undergoing lung biopsy need a postoperative chest drain at all? Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):1022-5. doi: 10.1510/icvts.2010.232892. Epub 2010 Mar 22.'}, {'pmid': '27510705', 'type': 'RESULT', 'citation': 'Holbek BL, Hansen HJ, Kehlet H, Petersen RH. Thoracoscopic pulmonary wedge resection without post-operative chest drain: an observational study. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):612-7. doi: 10.1007/s11748-016-0692-6. Epub 2016 Aug 10.'}, {'pmid': '30233854', 'type': 'RESULT', 'citation': 'Park JB, Hwang JJ, Lee WS, Kim YH, Lee SA. Postoperative chest tube placement after thoracoscopic wedge resection of lung for primary spontaneous pneumothorax: is it mandatory? J Thorac Dis. 2018 Aug;10(8):4812-4818. doi: 10.21037/jtd.2018.07.13.'}, {'pmid': '31843633', 'type': 'RESULT', 'citation': 'Liao HC, Yang SM, Hung MH, Cheng YJ, Hsu HH, Chen JS. Thoracoscopic Surgery Without Drainage Tube Placement for Peripheral Lung Nodules. Ann Thorac Surg. 2020 Mar;109(3):887-893. doi: 10.1016/j.athoracsur.2019.10.048. Epub 2019 Dec 13.'}, {'pmid': '31288906', 'type': 'RESULT', 'citation': 'Lesser T, Doenst T, Lehmann T, Mukdessi J. Lung Bioposy Without Pleural Drainage. Dtsch Arztebl Int. 2019 May 10;116(19):329-334. doi: 10.3238/arztebl.2019.0329.'}, {'pmid': '20334632', 'type': 'RESULT', 'citation': 'Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.'}, {'pmid': '7866172', 'type': 'RESULT', 'citation': 'Altman DG, Bland JM. Statistics notes: the normal distribution. BMJ. 1995 Feb 4;310(6975):298. doi: 10.1136/bmj.310.6975.298. No abstract available.'}, {'pmid': '8620137', 'type': 'RESULT', 'citation': 'Bland JM, Altman DG. The use of transformation when comparing two means. BMJ. 1996 May 4;312(7039):1153. doi: 10.1136/bmj.312.7039.1153. No abstract available.'}, {'pmid': '25971435', 'type': 'RESULT', 'citation': 'Hickey GL, Dunning J, Seifert B, Sodeck G, Carr MJ, Burger HU, Beyersdorf F; EJCTS and ICVTS Editorial Committees. Statistical and data reporting guidelines for the European Journal of Cardio-Thoracic Surgery and the Interactive CardioVascular and Thoracic Surgery. Eur J Cardiothorac Surg. 2015 Aug;48(2):180-93. doi: 10.1093/ejcts/ezv168. Epub 2015 May 12.'}, {'pmid': '8173371', 'type': 'RESULT', 'citation': 'Bland JM, Altman DG. Correlation, regression, and repeated data. BMJ. 1994 Apr 2;308(6933):896. doi: 10.1136/bmj.308.6933.896. No abstract available.'}, {'pmid': '25956159', 'type': 'RESULT', 'citation': 'Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.'}, {'pmid': '19638912', 'type': 'RESULT', 'citation': 'Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.'}, {'pmid': '25867135', 'type': 'RESULT', 'citation': 'Kleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand. 2015 Aug;59(7):912-20. doi: 10.1111/aas.12525. Epub 2015 Apr 13.'}, {'pmid': '23411725', 'type': 'RESULT', 'citation': 'Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.'}, {'pmid': '11171742', 'type': 'RESULT', 'citation': 'Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590-602. doi: 10.1378/chest.119.2.590.'}, {'pmid': '32642128', 'type': 'RESULT', 'citation': 'Akamine T, Kometani T, Hashinokuchi A, Akamine S, Shikada Y, Wataya H. Interpleural distance predicts persistent air leak after initial primary spontaneous pneumothorax. J Thorac Dis. 2020 May;12(5):2228-2235. doi: 10.21037/jtd.2020.04.48.'}, {'pmid': '15273542', 'type': 'RESULT', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '23977470', 'type': 'RESULT', 'citation': 'Hansen HJ, Petersen RH. Video-assisted thoracoscopic lobectomy using a standardized three-port anterior approach - The Copenhagen experience. Ann Cardiothorac Surg. 2012 May;1(1):70-6. doi: 10.3978/j.issn.2225-319X.2012.04.15. No abstract available.'}, {'pmid': '25558501', 'type': 'RESULT', 'citation': 'Zhou Q. [Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals]. Zhonghua Gan Zang Bing Za Zhi. 2014 Oct;22(10):781-91. No abstract available. Chinese.'}, {'pmid': '38382951', 'type': 'DERIVED', 'citation': 'Holbek BL, Huang L, Christensen TD, Bendixen M, Hansen HJ, Kehlet H, Petersen RH. Efficacy of avoiding chest drains after video-assisted thoracoscopic surgery wedge resection: protocol for a randomised controlled trial. BMJ Open. 2024 Feb 20;14(2):e080573. doi: 10.1136/bmjopen-2023-080573.'}]}, 'descriptionModule': {'briefSummary': 'Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease.\n\nHypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.\n* first second forced expiratory volume ≥60% of expected.\n* No increased bleeding risk (e.g. preoperative international normalized ratio \\>2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).\n* Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.\n* Able and willing to give informed consent.\n\nExclusion Criteria:\n\n* Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).\n* Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).\n* Air leak during intraoperative air leak test.'}, 'identificationModule': {'nctId': 'NCT05358158', 'acronym': 'CREATOR', 'briefTitle': 'Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection', 'orgStudyIdInfo': {'id': 'H-21012837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drain-free group', 'description': 'Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.', 'interventionNames': ['Procedure: Intraoperative air leak test', 'Procedure: Intraoperative chest drain removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chest drain group', 'description': 'Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.', 'interventionNames': ['Procedure: Intraoperative air leak test', 'Procedure: Standard chest drain placement']}], 'interventions': [{'name': 'Intraoperative air leak test', 'type': 'PROCEDURE', 'description': 'A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.', 'armGroupLabels': ['Chest drain group', 'Drain-free group']}, {'name': 'Intraoperative chest drain removal', 'type': 'PROCEDURE', 'description': 'Chest drain is removed intraoperatively.', 'armGroupLabels': ['Drain-free group']}, {'name': 'Standard chest drain placement', 'type': 'PROCEDURE', 'description': 'Chest drain is left in pleura.', 'armGroupLabels': ['Chest drain group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Thomas Decker Christensen', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'René H Petersen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Thomas D Christensen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Bo L Holbek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Morten Bendixen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Jonas J Rasmussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Henrik Kehlet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Henrik J Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The time when summary data are published.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication are planned to share to other researchers if they connect with the corresponding author of the publication.', 'accessCriteria': 'Others who need the IPD and relevant information should ask the correspoding author of the publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of cardiothoracic surgery', 'investigatorFullName': 'Lin Huang', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}