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Completed

NCT Number: NCT07827885

20-Fr Versus 24-Fr Chest Drains After Uniportal VATS Lobectomy for NSCLC

This randomized clinical trial compared two different chest drain sizes, 20 Fr and 24 Fr, in patients undergoing lung lobectomy for lung cancer. The study aimed to determine whether the size of the chest drain affects postoperative recovery. Outcomes included the presence of pneumothorax and pleural effusion, postoperative pain, subcutaneous emphysema, prolonged air leak, duration of chest drainage, and length of hospital stay. A total of 80 patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, 00142, Italy

About this study

Chest drainage is routinely used after pulmonary lobectomy to evacuate air and fluid from the pleural cavity and promote lung re-expansion. However, the optimal chest drain size after minimally invasive lung surgery remains uncertain. Smaller chest drains may improve patient comfort and reduce postoperative pain, but their ability to provide adequate pleural drainage compared with larger drains requires evaluation.

This single-center, prospective, randomized interventional study compared 20-Fr and 24-Fr chest drains in patients undergoing uniportal video-assisted thoracoscopic (uVATS) lung lobectomy with systematic mediastinal lymphadenectomy for non-small cell lung cancer (NSCLC). Eligible patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr thoracic drain at the end of surgery.

Postoperative assessment included radiographic evaluation for pneumothorax and residual pleural effusion, as well as evaluation of subcutaneous emphysema, prolonged air leak, analgesic use, postoperative pain using the Numerical Rating Scale, chest drain duration, and length of hospital stay. The study was designed to evaluate whether chest drain size influences postoperative clinical outcomes and patient comfort following minimally invasive pulmonary lobectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing pulmonary lobectomy with systematic mediastinal lymphadenectomy for lung cancer using a uniportal video-assisted thoracoscopic approach.
  • FEV1/FVC >70%.
  • Clinical stage up to and including stage IIB according to the eighth or ninth edition of the TNM classification.
  • No morphological evidence of macrobullous emphysema on computed tomography.

Exclusion criteria

  • Neoadjuvant chemoradiotherapy.
  • Previous ipsilateral pulmonary resection.
  • FEV1/FVC <70%.
  • Clinical stage beyond IIB according to the eighth or ninth edition of the TNM classification.
  • Macrobullous emphysema on computed tomography.
  • pregnant and breastfeeding women

Treatment and study plan

20-Fr Thoracic Drain

Device

A 20-Fr thoracic drain was placed at the end of video-assisted thoracoscopic lobectomy. The device was used for postoperative pleural and air evacuation.

24-Fr Thoracic Drain

Device

A 24-Fr thoracic drain was placed at the end of video-assisted thoracoscopic lobectomy. The device was used for postoperative pleural and air evacuation.

Primary outcomes

  1. Postoperative Pneumothorax (PNX)

    Time frame: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)

    Presence of postoperative PNX assessed by chest X-Ray.

  2. Postoperative Pleural Effusion

    Time frame: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)

    Presence of residual postoperative pleural effusion assessed by chest X-Ray

Secondary outcomes

  1. Postoperative Subcutaneous Emphysema

    Time frame: During postoperative hospitalization

    Presence of subcutaneous emphysema during the postoperative course.

  2. Postoperative Analgesic Use

    Time frame: Immediately after surgery to hospital discharge

    Use of analgesic medications during postoperative recovery.

  3. Prolonged Air Leak

    Time frame: From surgery through chest drain removal, with prolonged air leak defined as lasting more than 5 postoperative days, assessed up to 30 days after surgery

    Presence of postoperative air leak

  4. Chest Drain Duration

    Time frame: Immediately after surgery to chest drain removal, assessed up to 30 days after surgery

    Number of days from surgery to chest drain removal

  5. Length of Hospital Stay

    Time frame: Immediate after surgery to hospital discharge, assessed up to 30 days after surgery

    Number of days from surgery to hospital discharge

  6. Postoperative Pain

    Time frame: 12, 24, and 48 hours after surgery

    Postoperative pain intensity assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Official study title

Prospective Randomized Comparative Evaluation of Different Chest Drainage Devices in Patients Undergoing Lung Lobectomy

Acronym: DRAIN2024

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

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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