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Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor

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ClinicalTrials.gov Identifier: NCT03537430
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Xueying Yang, Shengjing Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Mediastinal Tumor Procedure: TNT uniportal VATS mediastinal tumor resection Procedure: Traditional uniportal VATS mediastinal tumor resection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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)
Masking Description: This study is a prospective randomized controlled clinical trial. Participants, care provider, and investigator all know the grouping situation. The Investigator collect the information and observation indicators of the two groups of participants and send to the Outcomes Assessor . The Outcomes Assessor does not know the grouping situation of each participant.
Primary Purpose: Treatment
Official Title: Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor: A Prospective Randomized Controlled Trial
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : August 15, 2019
Actual Study Completion Date : August 20, 2019

Arm Intervention/treatment
TNT Uniportal Video-assisted Thoracoscopic Surgery
This group of patients underwent TNT uniportal VATS mediastinal tumor resection
Procedure: TNT 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.

Uniportal Video-assisted Thoracoscopic Surgery
This group of patients underwent traditional uniportal VATS mediastinal tumor resection
Procedure: Traditional uniportal VATS mediastinal tumor resection
The surgical procedures followed principles of mediastinal tumor resection,uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.




Primary Outcome Measures :
  1. operative time [ Time Frame: 1 day ]
    Anesthesia completed to the end of the operation

  2. Intubation/laryngeal mask completion time [ Time Frame: 1 day ]
    Intubation/laryngeal mask completion time

  3. duration of postoperative pain [ Time Frame: 10 days ]
    Postoperative pain duration

  4. VAS pain scores [ Time Frame: 5 days ]
    The VAS pain score was given to patients and the pain scores were recorded at 6h, 12h, 24h, 48h, and 72h postoperatively.

  5. Intraoperative blood loss [ Time Frame: 1 day ]
    Intraoperative blood loss

  6. The time of early ambulation after operation [ Time Frame: 1 day ]
    The time from the patient's postoperative pushback to the first bedtime

  7. Postoperative hospital stay [ Time Frame: 15 days ]
    Postoperative hospital stay

  8. hospitalization expenses [ Time Frame: 15 days ]
    The total cost of hospitalization

  9. Intraoperative oxygen saturation, SpO2 [ Time Frame: 1 day ]
    Intraoperative oxygen saturation, SpO2

  10. Intraoperative mean arterial pressure, MAP [ Time Frame: 1 day ]
    Intraoperative mean arterial pressure, MAP

  11. postoperative complication rate [ Time Frame: 15 days ]
    Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications

  12. Intraoperative heart rate, HR [ Time Frame: 1 day ]
    Intraoperative heart rate, HR

  13. Postoperative extubation time [ Time Frame: 1 day ]
    Postoperative extubation time

  14. Postoperative feeding time [ Time Frame: 1 day ]
    Postoperative feeding time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537430


Locations
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China, Liaoning
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Sponsors and Collaborators
Xueying Yang
Publications of Results:

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Responsible Party: Xueying Yang, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03537430    
Other Study ID Numbers: EC-2018-HS-001
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xueying Yang, Shengjing Hospital:
TNT (Totally no tube)
uniportal VATS
mediastinal tumor
Additional relevant MeSH terms:
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Mediastinal Neoplasms
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases