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

Not Applicable

Completed

• Conditions: Chest Tube
• Interventions: Other: Large size tube; Other: Drainage ball

• Registration Number: NCT03598296
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-07-15
• Study First Posted: 2018-07-26
• Study Start: 2018-07-28
• Primary Completion: 2018-09-30
• Study Completion: 2018-10-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A:Group Tube	Large size 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 B:Group Ball	Drainage 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.

Primary Outcome Measures

Name	Time	Method
Hospitalization days	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 Outcome Measures

Name	Time	Method
Analgesics	Counting the total analgesics using times through study completion, an average of 3 months.	The number of analgesics using after surgery.
Drainage	Measure the volume every 24 hours,up to 4 weeks	The total volume of fluid.
Adverse event	Counting the times of adverse events through study completion, an average of 3 months.	Air-leakage or seepage from the surrounding of tube.
Pulmonary recruitment	The first 24 hours after surgery and 8 hours before leaving hospital.	Chest X-Ray
VAS scores	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.

Trial Locations

Locations (1)

First Affiliated Hospital, Soochow University; 🇨🇳 Suzhou, Jiangsu, China