The Affection of Two Chest Management for Enhanced Recovery Program After Video-assisted Thoracoscopic Lobectomy.

Chest Tube Clinical Trial

Official title:

Comparison of the Results of Two Chest Tube Management During an Enhanced Recovery Program After Video-Assisted Thoracoscopic Lobectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598296
• Other study ID #: 201805
• Status: Completed
• Phase: N/A
• Start date: July 28, 2018
• Est. completion date: October 27, 2018

Study information

• Verified date: July 2019
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 27, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Tube

Intervention

Other:
• Large size tube
Patients in Group A are inserted the large size tube (28F).
• Drainage ball
Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).

Locations

Country	Name	City	State
China	First Affiliated Hospital, Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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, Mar — View Citation

Göttgens 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization days	The numbers of days of patients stay in the hospital after surgery	From the first days after surgery to discharge,up to 4 weeks.
Secondary	VAS scores	VAS(Visual Analogue Score) is a method to value the degree of patient's pain after surgery.This method has a scale range from 1 to 10.Patient chose a number from it to represent his(her) pain.The "1" represents painless and the "10" represents sever pain which he(she) unable to bear. The pain is increasing with the increasing of number.	Pain is measured by VAS on the first 24 hours of after operation and the first 24 hours after tube removing.
Secondary	Analgesics	The number of analgesics using after surgery.	Counting the total analgesics using times through study completion, an average of 3 months.
Secondary	Drainage	The total volume of fluid.	Measure the volume every 24 hours,up to 4 weeks
Secondary	Pulmonary recruitment	Chest X-Ray	The first 24 hours after surgery and 8 hours before leaving hospital.
Secondary	Adverse event	Air-leakage or seepage from the surrounding of tube.	Counting the times of adverse events through study completion, an average of 3 months.