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

NCT07827885 | Completed

• 1 other identifier: 163.25 CET2 cbm
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

chest drain; chest tube; thoracic drainage; drain size; uniportal VATS; video-assisted thoracoscopic surgery; lung lobectomy; lung cancer; postoperative pain; thoracic surgery

Outcome Measures

Primary Outcomes (2)

• Postoperative Pneumothorax (PNX)

  Presence of postoperative PNX assessed by chest X-Ray.

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

• Postoperative Pleural Effusion

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

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

Secondary Outcomes (6)

• Postoperative Subcutaneous Emphysema

  During postoperative hospitalization

• Postoperative Analgesic Use

  Immediately after surgery to hospital discharge

• Prolonged Air Leak

  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

• Chest Drain Duration

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

• Length of Hospital Stay

  Immediate after surgery to hospital discharge, assessed up to 30 days after surgery

Study Arms (2)

20-Fr Chest Drain

EXPERIMENTAL

Patients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 20-Fr thoracic drain at the end of surgery.

Device: 20-Fr Thoracic Drain

24-Fr Chest Drain

ACTIVE COMPARATOR

Patients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 24-Fr thoracic drain at the end of surgery.

Device: 24-Fr Thoracic Drain

Interventions

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.

20-Fr Chest Drain

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.

24-Fr Chest Drain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, 00142, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pierfilippo Crucitti, MD Prof.

  Department of Thoracic Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain after uniportal video-assisted thoracoscopic lobectomy.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 18, 2026
• Study Start: July 24, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)