16F vs 24F chest drain after minimally invasive lobectomy or segmentectomy
Comparison of 16F Versus 24F Chest Drain After Minimally Invasive Pulmonary Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial
NA · University Hospital, Basel, Switzerland · NCT06958848
This study will test whether using a smaller 16F chest drain causes less postoperative pain than the standard 24F drain for adults having minimally invasive lobectomy or segmentectomy for lung cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT06958848 on ClinicalTrials.gov |
What this trial studies
Adults undergoing minimally invasive anatomical lung resection (lobectomy or segmentectomy) will receive either a 16F or a 24F chest tube, with predefined protocols for early or standard removal. Postoperative pain scores, respiratory function, and drain-related complications such as air leak and pleural effusion will be recorded and compared between groups. The study is conducted at University Hospital Basel and enrolls patients who meet operative and medical eligibility criteria. The goal is to determine whether a smaller-bore drain reduces pain without increasing postoperative complications.
Who should consider this trial
Good fit: Adults (≥18) with resectable non-small cell lung cancer scheduled for minimally invasive lobectomy or segmentectomy who can give informed consent and do not have recent ipsilateral thoracic surgery, pleural empyema, severe organ failure, dialysis dependence, or chronic opioid/neuropathic pain medication use.
Not a fit: Patients with complicating conditions such as pleural empyema, recent ipsilateral thoracic surgery, chronic opioid or gabapentin/pregabalin use, advanced heart failure (NYHA III–IV), significant liver cirrhosis, or dialysis-dependent renal failure are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, a smaller 16F chest drain could reduce early postoperative pain, improve breathing, and speed recovery after minimally invasive lung resection.
How similar studies have performed: Previous comparisons of small-bore versus large-bore chest drains after thoracic procedures have produced mixed but encouraging results, with some studies showing less pain and similar drainage effectiveness, though evidence is not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent signed by the patient (all sex and gender) * Patients' age from ≥ 18 to no age limit at time of study inclusion * American Society of Anaesthesiologists (ASA) physical status classification I to IV * Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by minimally invasive surgical technique. * Minimally invasive anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, bilobectomy Exclusion Criteria: * Previous thoracic surgery on the same side within 3 months * Lung cancer complicated with pleural empyema * Patients with chronic pain who receive opioids/gabapentin/pregabalin * Patients who consume opiates/benzodiazepines * Congestive heart failure NYHA Class III or IV * Liver cirrhosis Child-Pugh Class B and C * Renal insufficiency requiring dialysis and/or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 * Patients with coagulopathy or bleeding disorders: von Willebrand disease, Hemophilia; Thrombocytopenia (\<50 G/l), requiring platelet transfusion * Patients with neuralgia * Chest pain (site of surgery) without taking painkillers, measured by VAS while coughing \> 10 mm * Not consolidated rib fractures (in the last 3 months) on the side of surgical procedure * Open anatomical lung resection, including pneumonectomy * Insertion of 2 or more chest tubes * Need for patient controlled intravenous anaesthesia or patient controlled epidural anaesthesia * Patients intubated/sedated (not suitable due to difficulties to fill out the pain survey)
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Makhmudbek Mallaev, MD — University Hospital, Basel, Switzerland
- Study coordinator: Helga Bachmann, MSc Clinical Research
- Email: helga.bachmann@usb.ch
- Phone: +41 (0)61 328 71 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pneumothorax, Pleural Effusion, Lung Surgery, Chest Drainage, Minimally Invasive Thoracoscopic Lobectomy, Minimally Invasive Thoracoscopic Segmentectomy