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

NCT ID: NCT03598296

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-28

Study Completion Date

2018-10-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Chest Tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A:Group Tube

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.

Group Type EXPERIMENTAL

Large size tube

Intervention Type OTHER

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

Group B:Group Ball

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.

Group Type EXPERIMENTAL

Drainage ball

Intervention Type OTHER

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

Interventions

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Large size tube

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

Intervention Type OTHER

Drainage ball

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

Intervention Type OTHER

Other Intervention Names

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Upper tube Upper tube

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhao Jun

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Soochow University

Cui zihan

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

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First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 26990499 (View on PubMed)

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.

Reference Type RESULT
PMID: 28404761 (View on PubMed)

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.

Reference Type RESULT
PMID: 29629194 (View on PubMed)

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.

Reference Type RESULT
PMID: 20833554 (View on PubMed)

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.

Reference Type RESULT
PMID: 25979532 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31475791 (View on PubMed)

Other Identifiers

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201805

Identifier Type: -

Identifier Source: org_study_id

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