Clinical trial NCT06958848: 16F vs 24F Chest Drain After Thoracoscopic Lobectomy and/or Segmentectomy
Official title: Comparison of 16F Versus 24F Chest Drain After Thoracoscopic Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pneumothorax
Pleural Effusion
Keywords: Lung Surgery
Chest Drainage
Thoracoscopic Lobectomy
Thoracoscopic Segmentectomy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 thoracoscopic lobectomy and/or segmentectomy.

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). Compared to traditional thoracotomy, VATS 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 thoracoscopic 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.

Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the patient (all sex and gender)
* Patients' age from ≥ 18 to ≤ 80 at time of study inclusion
* American Society of Anaesthesiologists (ASA) physical status classification I to III
* Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by VATS (UICC Stages 0-II according to Tumor Nodes Metastasis (TNM) Classification 8th edition and selected patients with UICC Stage IIIA) or pulmonary metastasis or pulmonary lesion resected by lobectomy and/or segmentectomy
* Thoracoscopic anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, VATS-bilobectomy

Exclusion Criteria:

* Previous thoracic surgery on the same side within 6 months
* Lung cancer complicated with pleural empyema
* Patients with chronic pain who receive opiates/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
* 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)

Primary outcomes:
measure: Postoperative chest pain
timeFrame: 2, 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home, on average up to 10 days postoperative
Secondary outcomes:
measure: Postoperative acute pain relief while coughing
timeFrame: 2, 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home, on average up to 10 days postoperative
measure: Postoperative acute pain relief at rest
timeFrame: 2, 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home, on average up to 10 days postoperative
measure: Analgesia consumption
timeFrame: 2, 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home, on average up to 10 days postoperative; on 30- and 90 day follow up
measure: Duration of the thoracic drainage
timeFrame: From 2 until 6 hours post-surgery
measure: Fluid output
timeFrame: 2, 4 and 6 hours after last suture; twice daily from day 1 until discharge home, on average up to 10 days postoperative
measure: Length of hospital stay
timeFrame: 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
measure: Re-hospitalization
timeFrame: During hospitalization until 90-day follow-up
measure: Postoperative morbidity
timeFrame: During hospitalization until 90-day follow-up
measure: Pleural complications
timeFrame: During hospitalization until 90-day follow-up
measure: Mortality
timeFrame: During hospitalization, 30 and 90 days after hospital discharge
measure: Chronic pain
timeFrame: 30 and 90 days after hospital discharge
measure: Quality of life assessment
timeFrame: Preoperative, at hospital discharge and at 30/90-day follow-up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Didier Lardinois, MD
role: STUDY_CHAIR
affiliation: University Hospital, Basel, Switzerland
name: Makhmudbek Mallaev
role: PRINCIPAL_INVESTIGATOR
References: