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N/A N=216 Randomized Treatment

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

Lung Cancer · Complication of Surgical Procedure

Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days. — 550; 580 ml

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
LigaSure™ (Device); Monopolar electrocautery (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.
550; 580
SECONDARY
Acute Phase Proteins Levels.
68.5; 69.2
SECONDARY
Local Temperature.
-0.1; -0.1

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.

Eligibility Criteria

Inclusion Criteria

  • Surgery performed by Video-Assisted Thoracic Surgery technique (VATS).
  • Mediastinal Lymph Node Dissection performed due to the European Society of Thoracic Surgeons
  • Patients must be informed and must sign and give written informed consent.

Exclusion Criteria

  • Preoperative radiotherapy.
  • Preoperative chemotherapy.
  • Mediastinoscopy or other surgical procedures of mediastinum prior to the present surgery.
  • Chest surgery on the side to be operated.
  • Conversion from VATS to thoracotomy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03125798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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