NCT03537430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

May 15, 2018

Last Update Submit

August 21, 2019

Conditions

Mediastinal Tumor

Keywords

TNT (Totally no tube)uniportal VATSmediastinal tumor

Outcome Measures

Primary Outcomes (14)

  • operative time

    Anesthesia completed to the end of the operation

    1 day

  • Intubation/laryngeal mask completion time

    Intubation/laryngeal mask completion time

    1 day

  • duration of postoperative pain

    Postoperative pain duration

    10 days

  • 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

  • Intraoperative blood loss

    Intraoperative blood loss

    1 day

  • The time of early ambulation after operation

    The time from the patient's postoperative pushback to the first bedtime

    1 day

  • Postoperative hospital stay

    Postoperative hospital stay

    15 days

  • hospitalization expenses

    The total cost of hospitalization

    15 days

  • Intraoperative oxygen saturation, SpO2

    Intraoperative oxygen saturation, SpO2

    1 day

  • Intraoperative mean arterial pressure, MAP

    Intraoperative mean arterial pressure, MAP

    1 day

  • postoperative complication rate

    Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications

    15 days

  • Intraoperative heart rate, HR

    Intraoperative heart rate, HR

    1 day

  • Postoperative extubation time

    Postoperative extubation time

    1 day

  • Postoperative feeding time

    Postoperative feeding time

    1 day

Study Arms (2)

TNT Uniportal Video-assisted Thoracoscopic Surgery

OTHER

This group of patients underwent TNT uniportal VATS mediastinal tumor resection

Procedure: TNT uniportal VATS mediastinal tumor resection

Uniportal Video-assisted Thoracoscopic Surgery

OTHER

This group of patients underwent traditional uniportal VATS mediastinal tumor resection

Procedure: Traditional uniportal VATS mediastinal tumor resection

Interventions

TNT uniportal VATS mediastinal tumor resectionPROCEDURE

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.

TNT Uniportal Video-assisted Thoracoscopic Surgery
Traditional uniportal VATS mediastinal tumor resectionPROCEDURE

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

Uniportal Video-assisted Thoracoscopic Surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Related Publications (11)

  • 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.

    PMID: 29078668RESULT

  • 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.

    PMID: 28007878RESULT

  • 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.

    PMID: 27686131RESULT

  • 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.

    PMID: 27621880RESULT

  • 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.

    PMID: 27134844RESULT

  • 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.

    PMID: 29701369RESULT

  • 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.

    PMID: 29682455RESULT

  • 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.

    PMID: 29078536RESULT

  • 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.

    PMID: 29078441RESULT

  • 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.

    PMID: 29078440RESULT

  • 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.

    PMID: 26693152RESULT

MeSH Terms

Conditions

Mediastinal Neoplasms

Condition Hierarchy (Ancestors)

Thoracic NeoplasmsNeoplasms by SiteNeoplasmsMediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

April 1, 2018

Primary Completion

August 15, 2019

Study Completion

August 20, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

CN(1)