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

Primary Purpose

Mediastinal Tumor

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TNT uniportal VATS mediastinal tumor resection
Traditional uniportal VATS mediastinal tumor resection
Sponsored by
Xueying Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mediastinal Tumor focused on measuring TNT (Totally no tube), uniportal VATS, mediastinal tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Fourth Affiliated Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

TNT Uniportal Video-assisted Thoracoscopic Surgery

Uniportal Video-assisted Thoracoscopic Surgery

Arm Description

This group of patients underwent TNT uniportal VATS mediastinal tumor resection

This group of patients underwent traditional uniportal VATS mediastinal tumor resection

Outcomes

Primary Outcome Measures

operative time
Anesthesia completed to the end of the operation
Intubation/laryngeal mask completion time
Intubation/laryngeal mask completion time
duration of postoperative pain
Postoperative pain duration
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.
Intraoperative blood loss
Intraoperative blood loss
The time of early ambulation after operation
The time from the patient's postoperative pushback to the first bedtime
Postoperative hospital stay
Postoperative hospital stay
hospitalization expenses
The total cost of hospitalization
Intraoperative oxygen saturation, SpO2
Intraoperative oxygen saturation, SpO2
Intraoperative mean arterial pressure, MAP
Intraoperative mean arterial pressure, MAP
postoperative complication rate
Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications
Intraoperative heart rate, HR
Intraoperative heart rate, HR
Postoperative extubation time
Postoperative extubation time
Postoperative feeding time
Postoperative feeding time

Secondary Outcome Measures

Full Information

First Posted
May 15, 2018
Last Updated
August 21, 2019
Sponsor
Xueying Yang
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1. Study Identification

Unique Protocol Identification Number
NCT03537430
Brief Title
Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor
Official Title
Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xueying Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Tumor
Keywords
TNT (Totally no tube), uniportal VATS, mediastinal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNT Uniportal Video-assisted Thoracoscopic Surgery
Arm Type
Other
Arm Description
This group of patients underwent TNT uniportal VATS mediastinal tumor resection
Arm Title
Uniportal Video-assisted Thoracoscopic Surgery
Arm Type
Other
Arm Description
This group of patients underwent traditional uniportal VATS mediastinal tumor resection
Intervention Type
Procedure
Intervention Name(s)
TNT uniportal VATS mediastinal tumor resection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional uniportal VATS mediastinal tumor resection
Intervention Description
The surgical procedures followed principles of mediastinal tumor resection,uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.
Primary Outcome Measure Information:
Title
operative time
Description
Anesthesia completed to the end of the operation
Time Frame
1 day
Title
Intubation/laryngeal mask completion time
Description
Intubation/laryngeal mask completion time
Time Frame
1 day
Title
duration of postoperative pain
Description
Postoperative pain duration
Time Frame
10 days
Title
VAS pain scores
Description
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
Title
Intraoperative blood loss
Description
Intraoperative blood loss
Time Frame
1 day
Title
The time of early ambulation after operation
Description
The time from the patient's postoperative pushback to the first bedtime
Time Frame
1 day
Title
Postoperative hospital stay
Description
Postoperative hospital stay
Time Frame
15 days
Title
hospitalization expenses
Description
The total cost of hospitalization
Time Frame
15 days
Title
Intraoperative oxygen saturation, SpO2
Description
Intraoperative oxygen saturation, SpO2
Time Frame
1 day
Title
Intraoperative mean arterial pressure, MAP
Description
Intraoperative mean arterial pressure, MAP
Time Frame
1 day
Title
postoperative complication rate
Description
Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications
Time Frame
15 days
Title
Intraoperative heart rate, HR
Description
Intraoperative heart rate, HR
Time Frame
1 day
Title
Postoperative extubation time
Description
Postoperative extubation time
Time Frame
1 day
Title
Postoperative feeding time
Description
Postoperative feeding time
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
The Fourth Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29078668
Citation
Zhao ZR, Lau RWH, Ng CSH. Anaesthesiology for uniportal VATS: double lumen, single lumen and tubeless. J Vis Surg. 2017 Aug 21;3:108. doi: 10.21037/jovs.2017.07.05. eCollection 2017.
Results Reference
result
PubMed Identifier
28007878
Citation
Petersen RH, Holbek BL, Hansen HJ, Kehlet H. Video-assisted thoracoscopic surgery-taking a step into the future. Eur J Cardiothorac Surg. 2017 Apr 1;51(4):694-695. doi: 10.1093/ejcts/ezw381. No abstract available.
Results Reference
result
PubMed Identifier
27686131
Citation
Mineo TC, Tamburrini A, Perroni G, Ambrogi V. 1000 cases of tubeless video-assisted thoracic surgery at the Rome Tor Vergata University. Future Oncol. 2016 Dec;12(23s):13-18. doi: 10.2217/fon-2016-0348. Epub 2016 Sep 30.
Results Reference
result
PubMed Identifier
27621880
Citation
Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02.
Results Reference
result
PubMed Identifier
27134844
Citation
Gonzalez-Rivas D, Yang Y, Guido W, Jiang G. Non-intubated (tubeless) uniportal video-assisted thoracoscopic lobectomy. Ann Cardiothorac Surg. 2016 Mar;5(2):151-3. doi: 10.21037/acs.2016.03.02. No abstract available.
Results Reference
result
PubMed Identifier
29701369
Citation
Fernandes P, Lareiro S, Vouga L, Guerra M, Miranda J. Uniportal Video-Assisted Thorascoscopic Surgery - The New Paradigm in the Surgical Treatment of Lung Cancer. Rev Port Cir Cardiotorac Vasc. 2017 Jul-Dec;24(3-4):127.
Results Reference
result
PubMed Identifier
29682455
Citation
Migliore M. Uniportal video-assisted thoracic surgery, and the uni-surgeon: new words for the contemporary world. J Vis Surg. 2018 Mar 7;4:45. doi: 10.21037/jovs.2018.02.11. eCollection 2018. Erratum In: J Vis Surg. 2018 Jun 30;4:127.
Results Reference
result
PubMed Identifier
29078536
Citation
Bedetti B, Solli P, Lawrence D, Panagiotopoulos N, Hayward M, Scarci M. Single port video-assisted thoracoscopic thymectomy. J Vis Surg. 2016 Sep 1;2:149. doi: 10.21037/jovs.2016.08.07. eCollection 2016.
Results Reference
result
PubMed Identifier
29078441
Citation
Ooi A, Sibayan M. Uniportal video assisted thoracoscopic surgery thymectomy (right approach). J Vis Surg. 2016 Jan 17;2:13. doi: 10.3978/j.issn.2221-2965.2015.12.14. eCollection 2016.
Results Reference
result
PubMed Identifier
29078440
Citation
Ooi A, Qiang F. Uniportal video assisted thoracoscopic surgery thymectomy (left approach). J Vis Surg. 2016 Jan 16;2:12. doi: 10.3978/j.issn.2221-2965.2015.12.18. eCollection 2016.
Results Reference
result
PubMed Identifier
26693152
Citation
Dunning J. Video-assisted thoracoscopic microthymectomy. Ann Cardiothorac Surg. 2015 Nov;4(6):550-5. doi: 10.3978/j.issn.2225-319X.2015.11.04.
Results Reference
result

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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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