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

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.

• Postoperative acute pain relief at rest [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.]
• Analgesia consumption [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.]
• Duration of the thoracic drainage [Time frame: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.]
• Fluid output [Time frame: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.]
• Length of hospital stay [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.]
• Re-hospitalization [Time frame: After hospital discharge until 180-day follow up.]
• Postoperative morbidity [Time frame: During hospitalization and follow up until 30-day follow up.]
• Pleural complications [Time frame: During hospitalization and follow up until 30-day follow up.]
• Mortality [Time frame: During hospitalization; 30 and 180 days after hospital discharge.]
• Chronic pain [Time frame: 30 and 180 days after hospital discharge.]
• Quality of life assessment [Time frame: Preoperative and at 30/180-day follow up.]