Clinical trial NCT06425601: A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Postoperative Complications
Keywords: VATS
lung lobectomy
postoperative pain
chest drain
analgesia
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Analgesics consumption
timeFrame: 2 days
measure: Need for peroral analgesia after the chest tube removal
timeFrame: 2 days
measure: Maximal inspiratory pressure
timeFrame: 2 days
measure: Maximal expiratory pressure
timeFrame: 2 days
measure: Visual analogue scale
timeFrame: 2 days
Secondary outcomes:
measure: Duration of chest drainage
timeFrame: 1 month
measure: Pneumothorax rate on the day of surgery
timeFrame: First day
measure: Pneumothorax rate after chest tube removal
timeFrame: 1 month
measure: Pleural effusion rate on the day of surgery
timeFrame: First day
measure: Pleural effusion rate after chest tube removal
timeFrame: 1 month
measure: Subcutaneous emphysema rate
timeFrame: 1 month
measure: Prolonged air leak rate
timeFrame: 1 month
measure: Reintervention rate
timeFrame: 1 month
measure: Duration of hospital stay
timeFrame: 1 month
measure: Respiratory complication rate
timeFrame: 1 month
measure: Readmission rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: UMC Ljubljana
name: Boris Greif
role: PRINCIPAL_INVESTIGATOR
References: