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

Mediastinal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537430
• Other study ID #: EC-2018-HS-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: August 2019
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 20, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mediastinal Neoplasms
• Mediastinal Tumor

Intervention

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

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xueying Yang

Country where clinical trial is conducted

China, 

References & Publications (11)

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. Review. — View 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- — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. Epub 2016 Sep 30. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	Anesthesia completed to the end of the operation	1 day
Primary	Intubation/laryngeal mask completion time	Intubation/laryngeal mask completion time	1 day
Primary	duration of postoperative pain	Postoperative pain duration	10 days
Primary	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.	5 days
Primary	Intraoperative blood loss	Intraoperative blood loss	1 day
Primary	The time of early ambulation after operation	The time from the patient's postoperative pushback to the first bedtime	1 day
Primary	Postoperative hospital stay	Postoperative hospital stay	15 days
Primary	hospitalization expenses	The total cost of hospitalization	15 days
Primary	Intraoperative oxygen saturation, SpO2	Intraoperative oxygen saturation, SpO2	1 day
Primary	Intraoperative mean arterial pressure, MAP	Intraoperative mean arterial pressure, MAP	1 day
Primary	postoperative complication rate	Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications	15 days
Primary	Intraoperative heart rate, HR	Intraoperative heart rate, HR	1 day
Primary	Postoperative extubation time	Postoperative extubation time	1 day
Primary	Postoperative feeding time	Postoperative feeding time	1 day