Clinical trial NCT03598296: The Affection of Two Chest Management for Enhanced Recovery Program After Video-assisted Thoracoscopic Lobectomy.
Official title: Comparison of the Results of Two Chest Tube Management During an Enhanced Recovery Program After Video-Assisted Thoracoscopic Lobectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Tube
Keywords: ERAS(Enhanced Recovery After Surgery)
Video-assisted thoracoscope lobectomy
Non-Small Cell Lung Cancer (NSCLC)
Chest tube
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Total 60 patients accept video-Assisted thoracoscopic lobectomy are divided into two groups(Group A and Group B) equally and randomly.Different group takes different chest tube managements.
Primary purpose: TREATMENT

Brief summary: Comparing the influences of different chest tube managements for enhanced recovery program after video-Assisted thoracoscopic lobectomy.

Detailed description: The Enhanced Recovery Program has a series of observation data contains hospitalization days, adverse events, drainage, extubation, visual analogue scale(VAS) scores and the number of analgesic using.The investigators plan to enroll 60 patients and divide them into two groups to compare the influences of different chest tube managements for enhanced recovery program after video-assisted thoracoscopic lobectomy.

Eligibility criteria: Inclusion Criteria:

* Only single lesion on the targeted lobe
* Considered as invasive carcinoma by preoperative computed tomography (CT) or -diagnosed by intraoperative pathology
* Patients have signed informed consent.

Exclusion Criteria:

* Patients have critical basic disease(diabetes and hypertension).
* Patients who lung function cannot undertake the lobectomy.
* The lesion has the possibility of metastasis.
* Finding serious adhesion to pleura during operation

Primary outcomes:
measure: Hospitalization days
timeFrame: From the first days after surgery to discharge,up to 4 weeks.
Secondary outcomes:
measure: VAS scores
timeFrame: Pain is measured by VAS on the first 24 hours of after operation and the first 24 hours after tube removing.
measure: Analgesics
timeFrame: Counting the total analgesics using times through study completion, an average of 3 months.
measure: Drainage
timeFrame: Measure the volume every 24 hours,up to 4 weeks
measure: Pulmonary recruitment
timeFrame: The first 24 hours after surgery and 8 hours before leaving hospital.
measure: Adverse event
timeFrame: Counting the times of adverse events through study completion, an average of 3 months.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital, Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Zhao Jun
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Soochow University
name: Cui zihan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wisely JC, Barclay KL. Effects of an Enhanced Recovery After Surgery programme on emergency surgical patients. ANZ J Surg. 2016 Nov;86(11):883-888. doi: 10.1111/ans.13465. Epub 2016 Mar 17.
citation: Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman J, Chirieac LR, D'Amico TA, DeCamp MM, Dilling TJ, Dobelbower M, Doebele RC, Govindan R, Gubens MA, Hennon M, Horn L, Komaki R, Lackner RP, Lanuti M, Leal TA, Leisch LJ, Lilenbaum R, Lin J, Loo BW Jr, Martins R, Otterson GA, Reckamp K, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer K, Yang SC, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Apr;15(4):504-535. doi: 10.6004/jnccn.2017.0050.
citation: Bertolaccini L, Rocco G, Crisci R, Solli P. Enhanced recovery after surgery protocols in video-assisted thoracic surgery lobectomies: the best is yet still to come? J Thorac Dis. 2018 Mar;10(Suppl 4):S493-S496. doi: 10.21037/jtd.2018.02.33. No abstract available.
citation: 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.
citation: Xie HY, Xu K, Tang JX, Bian W, Ma HT, Zhao J, Ni B. A prospective randomized, controlled trial deems a drainage of 300 ml/day safe before removal of the last chest drain after video-assisted thoracoscopic surgery lobectomy. Interact Cardiovasc Thorac Surg. 2015 Aug;21(2):200-5. doi: 10.1093/icvts/ivv115. Epub 2015 May 15.
citation: Cui Z, Zhang Y, Xu C, Ding C, Chen J, Li C, Zhao J. Comparison of the results of two chest tube managements during an enhanced recovery program after video-assisted thoracoscopic lobectomy: A randomized trial. Thorac Cancer. 2019 Oct;10(10):1993-1999. doi: 10.1111/1759-7714.13183. Epub 2019 Sep 2.