Clinical Trial: The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor

Brief Summary: Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.

Detailed Summary:
Sponsor: Tang-Du Hospital

Current Primary Outcome:

• Amount of bleeding [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  Measured by the difference between the wet weight and dry weight of surgical gauze
• Rate of conversions to thoracotomy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  Only in "3-Hole" subxiphorid group and VATS group
• Duration of operation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
• Mortality rate [ Time Frame: up to 10 years ]
  Death caused by operation or complications
• Overall survival [ Time Frame: up to 10 years ]
  From randomization to any cause of death
• Quality of life [ Time Frame: up to 10 years after operation ]
  Measured by EORTC QLQ-C30 (version 3) scale
• Number of Participants with Adverse Events [ Time Frame: up to 8weekss afte operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tang-Du Hospital

Dates:
Date Received: November 26, 2014
Date Started: August 2014
Date Completion: December 2024
Last Updated: December 10, 2014
Last Verified: December 2014