CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 216 enrolled
Drug / intervention
LigaSure™ +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03125798
NCT03125798N/ACompleted

Comparison of LigaSure Technology to the Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery (VATS) Lobectomy Followed by Systemic Lymphadenectomy: A Prospective Randomized Controlled Study

Wielkopolskie Centrum Pulmonologii i Torakochirurgii·interventional·Posted Apr 24, 2017·Updated Sep 3, 2024

In Brief

A clinical study evaluating LigaSure™ and Monopolar electrocautery for Lung Cancer and Complication of Surgical Procedure. Completed, enrolled 216 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 24, 2017
Enrollment StartMay 3, 2018
Primary CompletionNov 4, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.2 years ago

Interventions

LigaSure™device

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

Monopolar electrocauterydevice

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