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Completed

NCT Number: NCT03598296

The Affection of Two Chest Management for 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.

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Key information

Conditions

Chest Tube Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Large size tube

Other

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

Other names: Upper tube

Drainage ball

Other

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

Other names: Upper tube

Primary outcomes

  1. Hospitalization days

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

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

Secondary outcomes

  1. VAS scores

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

    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.

  2. Analgesics

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

    The number of analgesics using after surgery.

  3. Drainage

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

    The total volume of fluid.

  4. Pulmonary recruitment

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

    Chest X-Ray

  5. Adverse event

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

    Air-leakage or seepage from the surrounding of tube.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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