Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor
Condition: Mediastinal Tumor
MeSH terms: Mediastinal Neoplasms
Study type: Interventional

Summary: 
      TNT surgery is a new area of exploration and evolution in thoracic minimal invasive surgery.
      TNT Uniportal Video-assisted Thoracoscopic Surgery (VATS) has become popular during
      mediastinal tumors resection. However, there has been little randomized controlled trials
      into the associated feasibility and advantage. The aim of our RCT was to evaluate the
      feasibility and advantage of TNT Uniportal VATS for mediastinal tumors resection and its
      significance in Fast Track Surgery (FTS). This is a single-center prospective randomized
      controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors
      were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal
      tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal
      tumor resection (control group), the short-term perioperative outcomes would be reported
      here.
    

Detailed description: 
      This study was designed as a single-center prospective randomized controlled trial. The trial
      recruited patients aged from 18 to 75 years with a diagnosis of mediastinal tumor.
      Preoperative chest CT examination showed that shape of the mediastinal tumor was regular,
      boundary was clear, and maximum diameter of the mass was less than 4 cm. Other inclusion
      criteria included capability of giving consent and adequate organ function to tolerate
      uniportal thoracoscopy mediastinal tumor resection. The exclusion criteria are described as
      follows: preoperative examination showed that the tumor invaded the surrounding blood
      vessels, pericardium, lung and other tissues or had distant metastasis; preoperative
      complications include severe coronary heart disease, arrhythmia and other serious
      cardiopulmonary diseases; large masses, difficult surgical procedures; manifestations of
      myasthenia gravis; hypovolemia, blood disorders, or abnormal clotting mechanism; pulmonary
      function and arterial blood gas analysis showed that patients could not tolerate surgery;
      previous thoracotomy; inability to obtain consent. Furthermore, the exclusion criteria were
      defifined as follows: intraoperative pleural adhesion or technical challenge to achieve
      hemostasis that make conversion from VATS to thoracotomy; clinician decides the patient
      should not continue the trial according to individual condition; patient withdraws from the
      trial. According to International Conference on Harmonisation, all participants gave written
      informed consent. Our RCT was launched in April 2018, which conducted in accordance with the
      Declaration of Helsinki and good clinical practice according to the International Conference
      on Harmonization guidelines. The ethics committee of The Fourth Affiliated Hospital of
      Medical Sciences, Liaoning, China, approved this study (approval number: EC-2018-HS-01).

      After eligibility had been confirmed and inform consents obtained, the investigator
      registered patients to ensure allocation concealment. Next we randomly enrolled patients to
      TNT group and control group in accordance with a list of randomization numbers. This list was
      generated in the trial statistician's computer. Allocation was communicated by telephone by
      the trial coordinator. Neither patients nor any investigators were masked to treatment
      allocation.

      The patients underwent routine physical examination, hematologic and biochemical tests,
      arterial blood gas analysis, pulmonary function test and computed tomography. Uniportal VATS
      mediastinal tumor resection was the standard surgical intervention according to the protocol.
      Patients in TNT group underwent TNT uniportal VATS mediastinal tumor resection, patients in
      control group underwent traditional uniportal VATS. Pre-, peri-, and postoperative details
      and outcome variables of patients were collected.
    

Intervention name(s): TNT uniportal VATS mediastinal tumor resection; Traditional uniportal VATS mediastinal tumor resection
Intervention type(s): Procedure; Procedure
Intervention description(s): TNT uniportal video-assisted thoracoscopic surgery refers to the use of conventional uniportal video-assisted thoracoscopic surgery, the use of laryngeal mask anesthesia instead of tracheal intubation anesthesia, intraoperative catheter was not retained, postoperative chest catheter placement.; The surgical procedures followed principles of mediastinal tumor resection，uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TNT (Totally no tube); uniportal VATS; mediastinal tumor