Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy

Summary

Surgical treatment of lung cancer consists of two elements: anatomical lung resection (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node dissection (MLND). Since over last 15 years the growing rate of resection is performed by minimal invasive approach - video-assisted thoracoscopic surgery (VATS). The study is focused on the clinical and technical aspects of MLND during VATS lobectomy. The extension of lymph nodes resection is strictly specified. The main benefit of MLND for the patient is precise histopathological staging, which allows choosing the best therapeutic option of adjuvant therapy. MLND is related with potential minor and major complications (bleeding, increased volume of chest tube drainage, prolonged chest tube duration and hospital stay, chylothorax, left recurrent laryngeal nerve injury, injury of the bronchus, injury of the esophagus). The majority of complications are caused by thermal injury resulting from the use of heat-generating monopolar electrocautery that is commonly used during lymph nodes dissection. In addition, thermal energy generation in case of monopolar electrocautery may lead to systemic inflammatory response and increased surgical injury. High-energy sealing devices like LigaSure™ allow for dissection, coagulation and cutting with the single instrument. Compared to mechanical ligation techniques (vessel loops, clips) or monopolar electrocautery, LigaSure™ technology has been shown to reduce: intraoperative blood loss (in colorectal, gynecologic and urologic surgery), surgery time (in colorectal, gynecologic and urologic surgery), length of hospital stay (in gynecologic and urologic surgery). Investigators hypothesize that application of LigaSure™ in VATS anatomical resection may lead to diminished complications rate, lower systemic inflammatory response and shorter length of stay compared to monopolar electrocautery.

Conditions

• Lung Cancer
• Complication of Surgical Procedure

Interventions

DEVICE

LigaSure™

LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.

DEVICE

Monopolar electrocautery

Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii

  lead OTHER

Principal Investigators

• Cezary Piwkowski, Prof · Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-03

Primary Completion

2021-11-04

Completion

2021-11-04

FDA Device

Yes

Countries

• Poland

Study Locations