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

July 29, 2019 updated by: The First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • First Affiliated Hospital, SooChow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Large size tube
Patients in Group A are inserted the large size tube (28F).
Other Names:
  • Upper tube
Experimental: 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.
Other: Drainage ball
Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).
Other Names:
  • Upper tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the first days after surgery to discharge,up to 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain is measured by VAS on the first 24 hours of after operation and the first 24 hours after tube removing.
Analgesics
Time Frame: Counting the total analgesics using times through study completion, an average of 3 months.
The number of analgesics using after surgery.
Counting the total analgesics using times through study completion, an average of 3 months.
Drainage
Time Frame: Measure the volume every 24 hours,up to 4 weeks
The total volume of fluid.
Measure the volume every 24 hours,up to 4 weeks
Pulmonary recruitment
Time Frame: The first 24 hours after surgery and 8 hours before leaving hospital.
Chest X-Ray
The first 24 hours after surgery and 8 hours before leaving hospital.
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.
Counting the times of adverse events through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Study Director: Zhao Jun, The First Affiliated Hospital of Soochow University
  • Principal Investigator: Cui zihan, The First Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

October 27, 2018

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

July 15, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chest Tube

Clinical Trials on Large size tube

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe