Myasthenia Gravis, Thymectomy
Conditions
Keywords
3-Hole approach, extended thymectomy, myasthenia gravis, safety, effectiveness
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.
Interventions
PROCEDURE3-Hole subxiphorid and subcostal approach
3-Hole subxiphorid and subcostal approach anterior mediastinum tumor resection
PROCEDURETrans sternal approach
Trans sternal approach anterior mediastinum tumor resection
PROCEDUREVATS approach
Video-assisted thoracoscope anterior mediastinum tumor resection
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* MG with thymic hyperplasia, thymoma or other anterior mediastinum disease * Masaoka stagingⅠ-Ⅱ * Thymoma without MG * Mass diameter \<10cm * Inform Consent Form is signed
Exclusion criteria
* Unable to tolerate surgery * myasthenic crisis * Masaoka staging Ⅲ-Ⅳ * Patients who have undergone previous surgery or radiotherapy * pregnancy , breastfeeding or younger than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of bleeding | 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 | 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 | Participants will be followed for the duration of hospital stay, an expected average of 5 days | — |
| Mortality rate | up to 10 years | Death caused by operation or complications |
| Overall survival | up to 10 years | From randomization to any cause of death |
| Quality of life | up to 10 years after operation | Measured by EORTC QLQ-C30 (version 3) scale |
| Number of Participants with Adverse Events | up to 8weekss afte operation | — |
Countries
China
Contacts
Primary ContactYong-an Zhou, MD
Backup ContactQiang Lu, MD
Outcome results
None listed