Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2016-02-29
2017-11-14
Brief Summary
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Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10 cmH2O when looking at chest tube duration and complications.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
Post-operative suction is set to -2 cmH2O.
Suction is set to -2 cmH2O
Post-operative suction is set to -2 cmH2O (intervention).
Group 2
Post-operative suction is set to -10 cmH2O (standard treatment).
Suction is set to -10 cmH2O
Post-operative suction is set to -10 cmH2O (standard treatment).
Interventions
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Suction is set to -2 cmH2O
Post-operative suction is set to -2 cmH2O (intervention).
Suction is set to -10 cmH2O
Post-operative suction is set to -10 cmH2O (standard treatment).
Eligibility Criteria
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Inclusion Criteria
* Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.
Exclusion Criteria
* Chronic drain carrier.
* Planned open procedure.
* Planned resection of additional wedge, additional lobe or thoracic wall.
18 Years
ALL
No
Sponsors
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Medela AG
INDUSTRY
Rigshospitalet, Denmark
OTHER
Responsible Party
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Bo Laksáfoss Holbek
Medical doctor
Principal Investigators
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Bo L. Holbek, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Merete Christensen, MD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Jesper Ravn, MD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Marshall MB, Deeb ME, Bleier JI, Kucharczuk JC, Friedberg JS, Kaiser LR, Shrager JB. Suction vs water seal after pulmonary resection: a randomized prospective study. Chest. 2002 Mar;121(3):831-5. doi: 10.1378/chest.121.3.831.
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.
Brunelli A, Beretta E, Cassivi SD, Cerfolio RJ, Detterbeck F, Kiefer T, Miserocchi G, Shrager J, Singhal S, Van Raemdonck D, Varela G. Consensus definitions to promote an evidence-based approach to management of the pleural space. A collaborative proposal by ESTS, AATS, STS, and GTSC. Eur J Cardiothorac Surg. 2011 Aug;40(2):291-7. doi: 10.1016/j.ejcts.2011.05.020.
Gottgens KW, Siebenga J, Belgers EH, van Huijstee PJ, Bollen EC. Early removal of the chest tube after complete video-assisted thoracoscopic lobectomies. Eur J Cardiothorac Surg. 2011 Apr;39(4):575-8. doi: 10.1016/j.ejcts.2010.08.002. Epub 2010 Sep 15.
Cerfolio RJ, Varela G, Brunelli A. Digital and smart chest drainage systems to monitor air leaks: the birth of a new era? Thorac Surg Clin. 2010 Aug;20(3):413-20. doi: 10.1016/j.thorsurg.2010.03.007.
Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
Holbek BL, Christensen M, Hansen HJ, Kehlet H, Petersen RH. The effects of low suction on digital drainage devices after lobectomy using video-assisted thoracoscopic surgery: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):673-681. doi: 10.1093/ejcts/ezy361.
Other Identifiers
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H-15008900
Identifier Type: -
Identifier Source: org_study_id
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