Pleural Effusion, Pneumothorax
Conditions
Keywords
Lung Surgery, Chest Drainage, Minimally Invasive Thoracoscopic Lobectomy, Minimally Invasive Thoracoscopic Segmentectomy
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 minimally invasive pulmonary 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) 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.
Interventions
DEVICE16 F chest tube
Insertion of 16F chest tube
DEVICE24 F chest tube
Insertion of 24F chest tube
PROCEDUREEarly removal
Removal 2-6h after end of skin closure
PROCEDUREStandard removal
Removal 1day postoperative
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative chest pain | 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. | 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). |
| Postoperative acute pain relief while coughing | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative acute pain relief at rest | 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. | 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). |
| Analgesia consumption | 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. | Intraoperative and postoperative analgesia consumption at different time points. |
| Duration of the thoracic drainage | From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed. | Duration of the thoracic drainage in hours from skin closure until chest tube removal if the air flow is ≤ 20 ml/min. |
| Fluid output | From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed. | Duration of fluid output reported per 24h measured in ml/kg/24h with Medela Thopaz+™ until the chest tube is removed. |
| Length of hospital stay | 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. | Length of hospital stay in nights from the end of the operation to the time when the patient is fit for discharge. |
| Re-hospitalization | After hospital discharge until 180-day follow up. | Re-hospitalization due to pleural complications. |
| Postoperative morbidity | During hospitalization and follow up until 30-day follow up. | 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. |
| Pleural complications | During hospitalization and follow up until 30-day follow up. | 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). |
| Mortality | During hospitalization; 30 and 180 days after hospital discharge. | In-hospital mortality; 30-day and 180-day mortality. |
| Chronic pain | 30 and 180 days after hospital discharge. | Chronic pain intensity and pain quality assessment while coughing and at rest on 30/180-day after hospital discharge. |
| Quality of life assessment | Preoperative and at 30/180-day follow up. | Quality of life measured by Short Form 12 (SF-12) questionnaire. |
Countries
Switzerland
Contacts
CONTACTHelga Bachmann, MSc Clinical Research
CONTACTMakhmudbek Mallaev, MD
STUDY_CHAIRDidier Lardinois, MD
University Hospital, Basel, Switzerland
PRINCIPAL_INVESTIGATORMakhmudbek Mallaev, MD
University Hospital, Basel, Switzerland
Outcome results
None listed