ClinicalTrials.gg
RecruitingNCT06958848ChestDrainUpdated May 6, 2026

16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy

An interventional study of 16 F chest tube and 24 F chest tube in Pneumothorax and Pleural Effusion, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasive pulmonary lobectomy and/or segmentectomy.

Read the detailed description

Lung cancer remains the leading cause of cancer-related death worldwide, and surgical resection remains the treatment of choice for patients with resectable non-small cell lung cancer (NSCLC), particularly in early stages of the disease. Anatomical lung resections such as lobectomy and segmentectomy are commonly performed, increasingly through minimally invasive techniques like video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS). Compared to traditional thoracotomy, VATS and RATS has been associated with better postoperative outcomes, including less pain, shorter hospital stays, faster recovery, and improved quality of life.

After lung resections, the standard postoperative management involves the insertion of a chest drain to remove air and fluid from the pleural space and monitor for complications such as air leaks or bleeding. Traditionally, most thoracic surgery centres use a single large-bore chest tube, typically 24F in size, which remains in place at least until the first postoperative day. However, this practice is not based on strong evidence, and there is currently no consensus on the optimal size of the chest drain. In fact, removal of the chest tube has been shown to significantly improve ventilatory function and reduce pain, particularly in the early postoperative period.

The Chest Drain 16F vs 24F Study investigates whether the use of a smaller-bore chest drain (16F) leads to less postoperative pain compared to the standard large-bore 24F drain in patients undergoing minimally invasive pulmonary lobectomy and/or segmentectomy. In addition to comparing the tube sizes, the trial explores the safety and feasibility of early chest drain removal, defined as removal within 2 to 6 hours after surgery, provided that specific clinical criteria are met (e.g., minimal air leak and no signs of complications). While retrospective data and small prospective studies suggest that early removal and the use of smaller tubes may be beneficial, high-quality prospective data are lacking. This study aims to provide evidence to potentially change clinical practice by reducing patient discomfort without compromising safety.

02

Conditions studied

  • Pneumothorax
  • Pleural Effusion

Keywords

  • Lung Surgery
  • Chest Drainage
  • Minimally Invasive Thoracoscopic Lobectomy
  • Minimally Invasive Thoracoscopic Segmentectomy
03

In context

Pneumothorax

183 studies on the registry are indexed under Pneumothorax; 41 are open to participants now.

This study's planned enrollment of 124 is above the median of 100 across 111 interventional studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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 Class III or IV
  • Liver cirrhosis Class B and C
  • Renal insufficiency requiring dialysis and/or estimated (eGFR) \<30 mL/min/1.73 m2
  • Patients with coagulopathy or bleeding disorders: von Willebrand disease, Hemophilia; Thrombocytopenia (\<50 G/l), requiring 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)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    16F - early removal

    small-bore (16F) chest tubes, removal 2h until 6h after end of skin closure

    Device: 16 F chest tube · Procedure: Early removal

  • Experimental
    16F - standard removal

    small-bore (16F) chest tubes, removal 1 day postoperative

    Device: 16 F chest tube · Procedure: Standard removal

  • Experimental
    24F - early removal

    large-bore (24F) chest tubes, removal 2h until 6h after end of skin closure

    Device: 24 F chest tube · Procedure: Early removal

  • Active comparator
    24F - standard removal

    large-bore (24F) chest tubes, removal 1 day postoperative

    Device: 24 F chest tube · Procedure: Standard removal

Interventions

  • Device16 F chest tube

    Insertion of 16F chest tube

    Also known as: Small-bore chest tube

  • Device24 F chest tube

    Insertion of 24F chest tube

    Also known as: Large-bore chest tube

  • ProcedureEarly removal

    Removal 2-6h after end of skin closure

  • ProcedureStandard removal

    Removal 1day postoperative

06

What researchers measure

Primary outcomes

  1. Postoperative chest pain

    Postoperative pain related to the placed chest drain (16F versus 24F), measured on a visual analogue scale (VAS) while coughing at different time points from skin closure until standard chest drain removal. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm). Chest pain intensity is measured and recorded at rest and while coughing. For the current pain rating, the patient must be shown their last rating for comparison. The patient marks their information with a vertical line on the horizontal score line of the sheet paper. If needed, assistance with filling out the form will be provided. The evaluation is carried out by measuring the distance from the low anchor point to the marking; the recorded values are expressed in millimetres (0-100).

    Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.

  2. Postoperative acute pain relief while coughing

    Postoperative acute pain relief while coughing in the other 5 pairwise comparisons. Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).

    Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.

Secondary outcomes

  1. Postoperative acute pain relief at rest

    Postoperative acute pain relief at rest measured by an analgesia consumption adjusted pain intensity on a visual analogue scale at different time points in all subgroup comparisons. Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).

    Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.

  2. Analgesia consumption

    Intraoperative and postoperative analgesia consumption at different time points.

    Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.

  3. Duration of the thoracic drainage

    Duration of the thoracic drainage in hours from skin closure until chest tube removal if the air flow is ≤ 20 ml/min.

    Time frame: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.

  4. Fluid output

    Duration of fluid output reported per 24h measured in ml/kg/24h with Medela Thopaz+™ until the chest tube is removed.

    Time frame: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.

  5. Length of hospital stay

    Length of hospital stay in nights from the end of the operation to the time when the patient is fit for discharge.

    Time frame: Patients are discharged from hospital on the 3rd to 7th day, or stay up to the 10th day in case of prolonged air leak or re-operation.

  6. Re-hospitalization

    Re-hospitalization due to pleural complications.

    Time frame: After hospital discharge until 180-day follow up.

  7. Postoperative morbidity

    Postoperative morbidity related to the medical device and/or procedure. Respiratory, thoracic, mediastinal and cardiac adverse events (AE). Adverse events are recorded and described according to CTCAE 5.0.

    Time frame: During hospitalization and follow up until 30-day follow up.

  8. Pleural complications

    Pleural complications after early removal of chest tubes.The pleural complications will be graded according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).

    Time frame: During hospitalization and follow up until 30-day follow up.

  9. Mortality

    In-hospital mortality; 30-day and 180-day mortality.

    Time frame: During hospitalization; 30 and 180 days after hospital discharge.

  10. Chronic pain

    Chronic pain intensity and pain quality assessment while coughing and at rest on 30/180-day after hospital discharge.

    Time frame: 30 and 180 days after hospital discharge.

  11. Quality of life assessment

    Quality of life measured by Short Form 12 (SF-12) questionnaire.

    Time frame: Preoperative and at 30/180-day follow up.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Apr 2027, 23 months after the start.

Of 42 interventional studies with no phase under Pneumothorax, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 34. This study's planned 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2025
First posted
May 6, 2025
StartActual
May 1, 2025
Primary completionEst.
Apr 30, 2027
CompletionEst.
Aug 30, 2027
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06958848
Responsible party
Sponsor
First posted
May 6, 2025
Start date
May 1, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
May 6, 2026

Study contacts

Helga Bachmann, MSc Clinical Research
Contact
helga.bachmann@usb.ch
+41 (0)61 328 71 70
Makhmudbek Mallaev, MD
Contact
makhmudbek.mallaev@usb.ch
+41 (0)61 556 51 89
Didier Lardinois, MD
study chair · University Hospital, Basel, Switzerland
Makhmudbek Mallaev, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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