A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy

The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains

The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.

The main questions it aims to answer are:

• silicone chest drains are less painful compared to standard PVC drains?
• is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain
• Intervention / Treatment: Device: SIL drain; Device: PVC drain

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• primary lung cancer eligible for VATS lobectomy by tumor board meeting

Exclusion Criteria:

• age under 18 years
• high risk of post-operative complications (ASA > 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) < 15 ml/kg/min)
• tumors growing in parietal pleura
• extended lung resection diffuse
• previous surgery in the same hemithorax
• chronic pain
• chronic use of analgesics or sedatives
• surgical revision
• inability to participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silicone (SIL) group; For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used	Device: SIL drain; Silicone chest tube used for pleural space drainage after VATS lobectomy
Active Comparator: PVC group; For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used	Device: PVC drain; Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesics consumption	Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.	2 days
Need for peroral analgesia after the chest tube removal	Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.	2 days
Maximal inspiratory pressure	Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.	2 days
Maximal expiratory pressure	Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.	2 days
Visual analogue scale	Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of chest drainage	The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome.	1 month
Pneumothorax rate on the day of surgery	The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.	First day
Pneumothorax rate after chest tube removal	The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.	1 month
Pleural effusion rate on the day of surgery	The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.	First day
Pleural effusion rate after chest tube removal	The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.	1 month
Subcutaneous emphysema rate	The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome.	1 month
Prolonged air leak rate	The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome.	1 month
Reintervention rate	The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome.	1 month
Duration of hospital stay	Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome.	1 month
Respiratory complication rate	Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome.	1 month
Readmission rate	Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome.	1 month

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Boris Greif, UMC Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: analgesia; postoperative pain; VATS; lung lobectomy; chest drain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications
• Other Study ID Numbers: 0120-445/2019/8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No