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

University Medical Centre Ljubljana

Status: Completed

Conditions: Postoperative Complications; Postoperative Pain

Treatments: Device: PVC drain; Device: SIL drain

Study type: Interventional

Funder types: Other

Identifiers

NCT06425601

0120-445/2019/8

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Silicone (SIL) group

Experimental group

Description:

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

Treatment:

Device: SIL drain

PVC group

Active Comparator group

Description:

For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used

Treatment:

Device: PVC drain