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Completed

NCT Number: NCT06425601

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SIL drain

Device

Silicone chest tube used for pleural space drainage after VATS lobectomy

PVC drain

Device

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

Primary outcomes

  1. Analgesics consumption

    Time frame: 2 days

    Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.

  2. Need for peroral analgesia after the chest tube removal

    Time frame: 2 days

    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.

  3. Maximal inspiratory pressure

    Time frame: 2 days

    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.

  4. Maximal expiratory pressure

    Time frame: 2 days

    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.

  5. Visual analogue scale

    Time frame: 2 days

    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.

Secondary outcomes

  1. Duration of chest drainage

    Time frame: 1 month

    The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome.

  2. Pneumothorax rate on the day of surgery

    Time frame: First day

    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.

  3. Pneumothorax rate after chest tube removal

    Time frame: 1 month

    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.

  4. Pleural effusion rate on the day of surgery

    Time frame: First day

    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.

  5. Pleural effusion rate after chest tube removal

    Time frame: 1 month

    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.

  6. Subcutaneous emphysema rate

    Time frame: 1 month

    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.

  7. Prolonged air leak rate

    Time frame: 1 month

    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.

  8. Reintervention rate

    Time frame: 1 month

    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.

  9. Duration of hospital stay

    Time frame: 1 month

    Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome.

  10. Respiratory complication rate

    Time frame: 1 month

    Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome.

  11. Readmission rate

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 22, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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