Materials and methods
blood loss, cancer type, primary lung cancer
ENDO, BLOOD LOSS, OTHER SURGICAL PROCEDURES, THORACIC, POLAND, CAVITY, COMPLICATIONS, ADHESIONS
This pragmatic, parallel group, randomized controlled trial was approved by the Bioethics Committee of the Poznan University of Medical Sciences, Poznan, Poland (June 16, 2016; number 764/16), and registered at Eligible were patients admitted for VATS lobectomy and lymphadenectomy for suspected or confirmed primary lung cancer, age of 18 years or older, with the ability to read and understand the information regarding the study, and ability to give informed consent to participate. Exclusion criteria were preoperative radiotherapy or chemotherapy, prior mediastinoscopy or other surgical procedures involving the mediastinum, and ipsilateral chest surgery.Patients were enrolled in the study by the thoracic surgeons at admission to the department. All patients enrolled gave written informed consent to participate in the study. Using a 1:1 ratio, and a simple randomization technique, we randomly assigned patients to receive one of the two interventions: tissue dissection with the LigaSure device (the study group) or dissection with monopolar device (the control group). The assignment sequence was created with a Web-based random number generator (Operations were performed by one of five board-certified thoracic surgeons experienced in minimally invasive anatomical lung resections. After induction of general anesthesia, a temperature probe was inserted into the patient’s esophagus and positioned at the level of subcarinal nodes, based on the patient's height. The VATS approach consisted of a 4–5 cm-long utility incision in the fourth or fifth intercostal space and usually placement of one or two thoracic trocars. No rib spreaders were used. For the dissection of tissues (including adhesions, the pulmonary ligament, pleura, and all soft tissues surrounding vessels) and for lymphadenectomy, monopolar device was used in the control group and the LigaSure device in the study group. Endostaplers (Endo GIA; Medtronic) were used to divide the pulmonary vessels, bronchi, and interlobar fissures. In cases of conversion to thoracotomy, the incision was enlarged to anterolateral thoracotomy. After the anatomical resection, lymphadenectomy was performed. The lymph nodes removed during lymphadenectomy were counted after the surgery by another thoracic surgeon, who was blinded to patient’s group assignment. At the end of the surgery, one 24-F chest tube was inserted into the pleural cavity and connected to a digital drainage system (Thopaz + ; Medela, Baar, Switzerland). The chest tube was removed after resolution of air leak and when the fluid volume was < 250 mL for 24 h. Perioperative anticoagulation was guided by the Caprini risk assessment model.The primary outcome measure was total postoperative chest drainage volume, measured from the time the electronic drainage system was turned on at the end of surgery, until the chest tube was removed. Secondary outcome measures were the change in the intraesophageal temperature at the level of the subcarinal lymph nodes (calculated as the difference between the highest temperature during subcarinal nodes dissection and the temperature before subcarinal nodes dissection) and blood C-reactive protein (CRP) levels 72 h after surgery.We documented demographic characteristics, comorbidities, results of pulmonary function tests, and results of preoperative risk assessment. Data about surgery included approach, type of lobectomy, numbers of lymph nodes and lymph node stations removed, duration of surgery, and estimated blood loss. CRP levels were measured before surgery and 6 and 72 h afterwards. The composition of pleural fluid was evaluated 72 h after surgery for triglyceride levels and hematocrit. The patients were followed up to the 30Clinical outcomes, including complications, and cancer type and stage were documented in accordance with the European Society of Thoracic Surgery/Society of Thoracic Surgeons definitions [