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NCT Number: NCT03537430

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

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.

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Key information

Conditions

Mediastinal Tumor Mediastinal Diseases Mediastinal Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Thoracic Diseases Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110004, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TNT uniportal VATS mediastinal tumor resection

Procedure

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.

Traditional uniportal VATS mediastinal tumor resection

Procedure

The surgical procedures followed principles of mediastinal tumor resection，uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Xueying Yang

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 25, 2018
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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