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

NCT03598296 | Completed

• 1 other identifier: 201805
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chest Tube

Keywords

ERAS(Enhanced Recovery After Surgery); Video-assisted thoracoscope lobectomy; Non-Small Cell Lung Cancer (NSCLC); Chest tube

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• VAS scores

  Pain is measured by VAS on the first 24 hours of after operation and the first 24 hours after tube removing.

• Analgesics

  Counting the total analgesics using times through study completion, an average of 3 months.

• Drainage

  Measure the volume every 24 hours,up to 4 weeks

• Pulmonary recruitment

  The first 24 hours after surgery and 8 hours before leaving hospital.

• Adverse event

  Counting the times of adverse events through study completion, an average of 3 months.

Study Arms (2)

Group A:Group Tube

EXPERIMENTAL

Patients are inserted the large size tube (28F).Patients undergo upper lobectomy are inserted one additional large size tube(28F,we named this tube upper tube).This group is planned to enroll 30 patients.

Other: Large size tube

Group B:Group Ball

EXPERIMENTAL

Patients are inserted the small size tube connects with a negative pressure ball(drainage ball).Patients undergo upper lobectomy are inserted one additional large size tube(28F,we named this tube upper tube).This group is planned to enroll 30 patients.

Other: Drainage ball

Interventions

Large size tube OTHER

Patients in Group A are inserted the large size tube (28F).

Also known as: Upper tube

Group A:Group Tube

Drainage ball OTHER

Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).

Also known as: Upper tube

Group B:Group Ball

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

Location

Related Publications (6)

• 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.

  PMID: 26990499 RESULT

• 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.

  PMID: 28404761 RESULT

• 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.

  PMID: 29629194 RESULT

• 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: 20833554 RESULT

• 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.

  PMID: 25979532 RESULT

• 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.

  PMID: 31475791 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhao Jun

  The First Affiliated Hospital of Soochow University

  STUDY DIRECTOR

• Cui zihan

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 26, 2018
• Study Start: July 28, 2018
• Primary Completion: September 30, 2018
• Study Completion: October 27, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)