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Chest TubeNCT03598296

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

A study testing Large size tube and Drainage ball in people with Chest Tube, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparing the influences of different chest tube managements for enhanced recovery program after video-Assisted thoracoscopic lobectomy. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Chest Tube
What is being tested?
Large size tube and Drainage ball
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
28 Jul 2018to 27 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital, Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

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

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

Read the 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.

Conditions
Chest Tube
Being tested
Large size tube, Drainage ball
Keywords
ERAS(Enhanced Recovery After Surgery), Video-assisted thoracoscope lobectomy, Non-Small Cell Lung Cancer (NSCLC), Chest tube
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Large size tubeOther

    Also called Upper tube

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

  • Drainage ballOther

    Also called Upper tube

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

Study groups in NCT03598296
Study groupRoleWhat they receive
Group A:Group TubeExperimentalPatients 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.
Receives: Other: Large size tube
Group B:Group BallExperimentalPatients 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.
Receives: Other: Drainage ball

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization days

    The numbers of days of patients stay in the hospital after surgery

    Measured: From the first days after surgery to discharge,up to 4 weeks.

Secondary outcomes (5)

  1. 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.

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

  2. Analgesics

    The number of analgesics using after surgery.

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

  3. Drainage

    The total volume of fluid.

    Measured: Measure the volume every 24 hours,up to 4 weeks

  4. Pulmonary recruitment

    Chest X-Ray

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

  5. Adverse event

    Air-leakage or seepage from the surrounding of tube.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start28 Jul 2018
  3. Primary completion30 Sep 2018
  4. Study completion27 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03598296
Sponsor's protocol ID
201805
Status last verified
Jul 2019
First submitted
7 Jun 2018
Last updated
30 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26990499

  • 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.

    PubMed 28404761

  • 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.

    PubMed 29629194

  • 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.

    PubMed 20833554

  • 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.

    PubMed 25979532

  • 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.

    PubMed 31475791

Questions about this trial

What is this clinical trial studying?

A study testing Large size tube and Drainage ball in people with Chest Tube, run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization days (time frame: From the first days after surgery to discharge,up to 4 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03598296, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.

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