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

NCT06425601 | Completed

• 1 other identifier: 0120-445/2019/8
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Postoperative Complications

Keywords

VATS; lung lobectomy; postoperative pain; chest drain; analgesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Duration of chest drainage

  1 month

• Pneumothorax rate on the day of surgery

  First day

• Pneumothorax rate after chest tube removal

  1 month

• Pleural effusion rate on the day of surgery

  First day

• Pleural effusion rate after chest tube removal

  1 month

Study Arms (2)

Silicone (SIL) group

EXPERIMENTAL

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

PVC group

ACTIVE COMPARATOR

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

Device: PVC drain

Interventions

SIL drain DEVICE

Silicone chest tube used for pleural space drainage after VATS lobectomy

Silicone (SIL) group

PVC drain DEVICE

Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy

PVC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Greif B, Zgajnar J, Stupnik T. Impact of chest tube type on pain, drainage efficacy, and short-term treatment outcome following video-assisted thoracoscopic surgery lobectomy: a randomized controlled trial comparing coaxial silicone drains and standard polyvinyl chloride drains. J Thorac Dis. 2025 Feb 28;17(2):932-943. doi: 10.21037/jtd-24-1489. Epub 2025 Feb 21.

  PMID: 40083488 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Agnosia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Boris Greif

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Thoracic Surgery

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 22, 2024
• Study Start: September 30, 2020
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

SL (1)