Comparison of LigaSure Technology to the Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery (VATS) Lobectomy Followed by Systemic Lymphadenectomy: A Prospective Randomized Controlled Study
Phase: NA
Conditions: Lung Cancer, Complication of Surgical Procedure
Sponsor: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

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Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted 
Thoracoscopic Surgery Lobectomy 
NCT03125798 
June 10,2016 
Aim: to compare the short-term results of and extent of surgical injury by the LigaSure 
device and monopolar electrocautery in patients undergoing VATS lobectomy with 
lymphadenectomy. 
Type of study: Pragmatic, parallel group, randomized controlled trial, simple randomization, 
1:1 allocation ratio 
Approval: Bioethics Committee of the Poznan University of Medical Sciences, Poznan, 
Poland 
Location: Department of Thoracic Surgery, Poznan University of Medical Sciences 
Inclusion criteria: admission for VATS lobectomy and lymphadenectomy for suspected or 
confirmed primary lung cancer, age of 18 years or older, ability to read and understand the 
information regarding the study, and ability to give informed consent to participate. 
Exclusion criteria: preoperative radiotherapy or chemotherapy, prior mediastinoscopy or 
other surgical procedures involving the mediastinum, and ipsilateral chest surgery. Patients 
who underwent conversion from VATS to thoracotomy were assessed for the relationship 
between conversion and intervention, but their data were excluded from the final analysis to 
avoid confounding. 
Enrollment: by the thoracic surgeons at admission to the department 

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Interventions: tissue dissection with the LigaSure device (the study group) or dissection with 
monopolar device (the control group).  
Concealment: to conceal assignments, sequentially numbered, opaque, sealed envelopes 
that will be prepared before the study and will be opened just before the surgery. From this 
point, patients’ assignments will be known to the surgeons. 
Surgery: after induction of general anesthesia, a temperature probe will be inserted into the 
patient’s esophagus and positioned at the level of subcarinal nodes. VATS lobectomy and 
lymphadenectomy will be performed with either the monopolar device or the LigaSure 
device. At the end of the surgery, one 24-F chest tube will be inserted into the pleural cavity 
and connected to a digital drainage system. The chest tube will be removed after resolution 
of air leak and when the fluid volume was <250 mL for 24 h. 
The primary outcome measure: postoperative drainage volume 
Secondary outcome measures: change in the esophageal temperature at the level of the 
subcarinal lymph nodes during lymphadenectomy and C-reactive protein levels 72 h after 
surgery. 
Data collection:  
1. Preoperative data: baseline characteristics, comorbidities, results of pulmonary 
function tests, laboratory tests results, and results of preoperative risk assessment.  
2. Surgery data: approach, type of lobectomy, numbers of lymph nodes and lymph node 
stations removed, duration of surgery, and estimated blood loss, esophageal 
temperature 

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3. Postoperative data: ICU admission, 24-hour and 48-hour and total volume of chest 
tube drainage, chest tube duration, laboratory evaluation of the pleural fluid 
composition after 24-hours (WBC, triglycerides, albumin), hospital stay, 
complications