CClinicalTrials.gg
Status unknownNCT02727218Updated Apr 6, 2016

Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies

An interventional study of Chest tube removal in Non-Neoplastic Thoracic Disorder and Lung Diseases, sponsored by Rambam Health Care Campus. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be divided into two groups, the first group will undergo early chest tube removal - after three hours, the second group will have late chest tube removal according to the department's protocol.

the study aims to prove the possibility and non inferiority for early chest tube removal for thoracoscopic surgeries with non complicated surgical course.

Read the detailed description

Presence of chest tube post thoracoscopic surgery is associated with increased morbidities like wound infection, pain, and prolong the hospital admission Corse, in the other hand, early chest tube removal is associated with increased the need for recurrent active intervention like pleural tapping for re-accumulated pleural effusion.

Method: randomized prospective study includes 60 patients who underwent thoracoscopic lobectomy/segmentectomy/ thoracoscopic mediastinal biopsy.

The study will exclude patients with difficult operative course ( intraoperative finding of significant adhesions/ intraoperative injury of the lung parenchyma/ intraoperative bleeding/failure of extubation ) and patient with post operative findings of ( bleeding in the chest tube more than 100 ml in the first hour, persistent air leak, non expanded lung on chest x-ray ) The patients will be divided into two groups, the first group - 30 patients - will undergo chest tube removal after three hours, and the second group will undergo chest tube removal according to the treating department protocol.

All patients will be evaluated regarding the pain level - subjective and objective -, admission period, infection, and the need for invasive intervention.

The patients will be evaluated during the admission, after one week and after two weeks.

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Conditions studied

  • Non-Neoplastic Thoracic Disorder
  • Lung Diseases

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03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient's who undergo thoracoscopic lung resection ( lobectomy or segmentectomy ), or thoracoscopic mediastinal biopsy.
  • post op there was no bleeding, the lung expanded, no persistent air leak, fluid discharge in the chest tube less than 100 ml, the patient underwent extubation.
  • patients with who read and signed informed consent regarding the participation of the study.

Exclusion criteria

Exclusion Criteria:

  • Patients who underwent thoracoscopic segmental resection due to primary spontaneous pneumothorax.
  • patients who underwent thoracoscopic pleural biopsy for possible malignancy.
  • patients under 18 year old.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    chest tube removal after 3 hours

    30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal after 3 hours.

    Procedure: Chest tube removal

  • Active comparator
    delayed chest tube removal

    30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal according to the department's protocol, most probably post operative day 1 (POD1)

    Procedure: Chest tube removal

Interventions

  • ProcedureChest tube removal

    chest tube removal post thoracoscopic surgery

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What researchers measure

Primary outcomes

  1. Non complicated early chest tube removal

    the patient with inclusion criteria can undergo early chest tube removal after three hours with no need for chest tube insertion, or pleural tapping for recurrent pleural effusion,

    Time frame: two weeks

  2. Complicated early chest tube removal

    Patients who underwent early chest tube removal 3 hours after surgery are more liable for reinsertion of chest tube or active pleural tapping.

    Time frame: two weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Chang AC, Yee J, Orringer MB, Iannettoni MD. Diagnostic thoracoscopic lung biopsy: an outpatient experience. Ann Thorac Surg. 2002 Dec;74(6):1942-6; discussion 1946-7. doi: 10.1016/s0003-4975(02)04164-4. PubMed 12643377 ↗
  • Gomez-Caro A, Roca MJ, Torres J, Cascales P, Terol E, Castaner J, Pinero A, Parrilla P. Successful use of a single chest drain postlobectomy instead of two classical drains: a randomized study. Eur J Cardiothorac Surg. 2006 Apr;29(4):562-6. doi: 10.1016/j.ejcts.2006.01.019. Epub 2006 Feb 21. PubMed 16495069 ↗
  • Okur E, Baysungur V, Tezel C, Sevilgen G, Ergene G, Gokce M, Halezeroglu S. Comparison of the single or double chest tube applications after pulmonary lobectomies. Eur J Cardiothorac Surg. 2009 Jan;35(1):32-5; discussion 35-6. doi: 10.1016/j.ejcts.2008.09.009. Epub 2008 Oct 16. PubMed 18929492 ↗
  • Younes RN, Gross JL, Aguiar S, Haddad FJ, Deheinzelin D. When to remove a chest tube? A randomized study with subsequent prospective consecutive validation. J Am Coll Surg. 2002 Nov;195(5):658-62. doi: 10.1016/s1072-7515(02)01332-7. PubMed 12437253 ↗
  • 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. PubMed 22219425 ↗
  • Yu H. Management of pleural effusion, empyema, and lung abscess. Semin Intervent Radiol. 2011 Mar;28(1):75-86. doi: 10.1055/s-0031-1273942. PubMed 22379278 ↗
  • Bjerregaard LS, Jensen K, Petersen RH, Hansen HJ. Early chest tube removal after video-assisted thoracic surgery lobectomy with serous fluid production up to 500 ml/day. Eur J Cardiothorac Surg. 2014 Feb;45(2):241-6. doi: 10.1093/ejcts/ezt376. Epub 2013 Jul 19. PubMed 23872457 ↗
  • McKenna RJ Jr, Mahtabifard A, Pickens A, Kusuanco D, Fuller CB. Fast-tracking after video-assisted thoracoscopic surgery lobectomy, segmentectomy, and pneumonectomy. Ann Thorac Surg. 2007 Nov;84(5):1663-7; discussion 1667-8. doi: 10.1016/j.athoracsur.2007.05.058. PubMed 17954081 ↗
  • Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066. PubMed 18242249 ↗
  • Nakanishi R, Fujino Y, Yamashita T, Oka S. A prospective study of the association between drainage volume within 24 hours after thoracoscopic lobectomy and postoperative morbidity. J Thorac Cardiovasc Surg. 2009 Jun;137(6):1394-9. doi: 10.1016/j.jtcvs.2008.10.035. Epub 2009 Mar 9. PubMed 19464455 ↗
  • 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. PubMed 20833554 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02727218
Lead sponsor
Rambam Health Care Campus
Responsible party
KATZ AMIT M.D. (Dr, Rambam Health Care Campus) — Principal investigator
First posted
Apr 4, 2016
Start date
May 2016
Primary completion
May 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Apr 6, 2016

Study contacts

Ran Kremer, MD
Contact
r_kremer@rambam.health.gov.il
00972502063189
Amit Katz, MD
Contact
amit160275@gmail.com
00972502062291
Ran Kremer, MD
study director · Rambam Health Care Campus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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