An interventional study of TNT uniportal VATS mediastinal tumor resection and Traditional uniportal VATS mediastinal tumor resection in Mediastinal Tumor, sponsored by Xueying Yang. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-22.
Sponsored by Xueying Yang · Not applicable, Interventional, and Treatment
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.
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.
25 studies on the registry are indexed under Mediastinal Neoplasms; 8 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 21 interventional studies indexed under Mediastinal Neoplasms.
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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.
Exclusion Criteria:
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.
This group of patients underwent TNT uniportal VATS mediastinal tumor resection
Procedure: TNT uniportal VATS mediastinal tumor resection
This group of patients underwent traditional uniportal VATS mediastinal tumor resection
Procedure: Traditional uniportal VATS mediastinal tumor resection
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.
operative time
Anesthesia completed to the end of the operation
Time frame: 1 day
Intubation/laryngeal mask completion time
Intubation/laryngeal mask completion time
Time frame: 1 day
duration of postoperative pain
Postoperative pain duration
Time frame: 10 days
VAS pain scores
The VAS pain score was given to patients and the pain scores were recorded at 6h, 12h, 24h, 48h, and 72h postoperatively.
Time frame: 5 days
Intraoperative blood loss
Intraoperative blood loss
Time frame: 1 day
The time of early ambulation after operation
The time from the patient's postoperative pushback to the first bedtime
Time frame: 1 day
Postoperative hospital stay
Postoperative hospital stay
Time frame: 15 days
hospitalization expenses
The total cost of hospitalization
Time frame: 15 days
Intraoperative oxygen saturation, SpO2
Intraoperative oxygen saturation, SpO2
Time frame: 1 day
Intraoperative mean arterial pressure, MAP
Intraoperative mean arterial pressure, MAP
Time frame: 1 day
postoperative complication rate
Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications
Time frame: 15 days
Intraoperative heart rate, HR
Intraoperative heart rate, HR
Time frame: 1 day
Postoperative extubation time
Postoperative extubation time
Time frame: 1 day
Postoperative feeding time
Postoperative feeding time
Time frame: 1 day
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Xueying Yang