NCT02727218

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

March 29, 2016

Last Update Submit

April 4, 2016

Conditions

Non-Neoplastic Thoracic DisorderLung Diseases

Outcome Measures

Primary Outcomes (2)

  • 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,

    two weeks

  • 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.

    two weeks

Study Arms (2)

chest tube removal after 3 hours

EXPERIMENTAL

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

Procedure: Chest tube removal

delayed chest tube removal

ACTIVE COMPARATOR

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

Chest tube removalPROCEDURE

chest tube removal post thoracoscopic surgery

chest tube removal after 3 hoursdelayed chest tube removal

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 12643377BACKGROUND

  • 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.

    PMID: 16495069BACKGROUND

  • 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.

    PMID: 18929492BACKGROUND

  • 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.

    PMID: 12437253BACKGROUND

  • 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: 22219425BACKGROUND

  • 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.

    PMID: 22379278BACKGROUND

  • 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.

    PMID: 23872457BACKGROUND

  • 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.

    PMID: 17954081BACKGROUND

  • 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.

    PMID: 18242249BACKGROUND

  • 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.

    PMID: 19464455BACKGROUND

  • 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.

    PMID: 20833554BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Ran Kremer, MD

    Rambam Health Care Campus

    STUDY DIRECTOR

Central Study Contacts

Ran Kremer, MD

CONTACT

00972502063189r_kremer@rambam.health.gov.il

Amit Katz, MD

CONTACT

00972502062291amit160275@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 4, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

April 6, 2016

Record last verified: 2016-04