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

August 21, 2019 updated by: Xueying Yang

Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor: A Prospective Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • the Fourth Affiliated Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: 1 day
Intraoperative blood loss
1 day
operative time
Time Frame: 1 day
Anesthesia completed to the end of the operation
1 day
Intubation/laryngeal mask completion time
Time Frame: 1 day
Intubation/laryngeal mask completion time
1 day
duration of postoperative pain
Time Frame: 10 days
Postoperative pain duration
10 days
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 days
The time of early ambulation after operation
Time Frame: 1 day
The time from the patient's postoperative pushback to the first bedtime
1 day
Postoperative hospital stay
Time Frame: 15 days
Postoperative hospital stay
15 days
hospitalization expenses
Time Frame: 15 days
The total cost of hospitalization
15 days
Intraoperative oxygen saturation, SpO2
Time Frame: 1 day
Intraoperative oxygen saturation, SpO2
1 day
Intraoperative mean arterial pressure, MAP
Time Frame: 1 day
Intraoperative mean arterial pressure, MAP
1 day
postoperative complication rate
Time Frame: 15 days
Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications
15 days
Intraoperative heart rate, HR
Time Frame: 1 day
Intraoperative heart rate, HR
1 day
Postoperative extubation time
Time Frame: 1 day
Postoperative extubation time
1 day
Postoperative feeding time
Time Frame: 1 day
Postoperative feeding time
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xueying Yang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

August 15, 2019

Study Completion (ACTUAL)

August 20, 2019

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (ACTUAL)

May 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-2018-HS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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