Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.
This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
Extended thymectomy performed through the traditional intercostal VATS approach
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
RECRUITINGShaoxing Center Hospital
Shaoxing, Zhejiang, China
RECRUITINGTaizhou Center Hospital (Taizhou Unoversity Hospital)
Taizhou, Zhejiang, China
RECRUITINGResection rate of thymus tissue
The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.
Time frame: 1 month
Acute Pain Score
Visual analogue score (VAS-score) is to asses the development of acute pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 24 hours after operation.
Time frame: 24 hours
Life Quality of Patients
The EuroQol 5 Dimensions (EQ-5D) is used. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. EQ-5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state.
Time frame: 6 months
Myasthenia Gravis remission rate
The Quantitative Myasthenia Gravis scale (QMG) is used. It includes 13 items, such as eyelid ptosis, diplopia, eyelid closure, speech, swallowing, vital capacity, lift, grip and lower extremity elevation. QMG can evaluate myasthenia, and total score of the scale is from 0 (no myasthenia) to 39 (the most severe myasthenia). If the difference between the two assessment scores is greater than 3.5, it is considered that the symptoms of myasthenia gravis relieved.
Time frame: 1 year
Disease-free survival
From grouping to the recurrence of disease or the time of death due to disease progression.
Time frame: Up to 5 years
Recurrence rate
The rate of patients recurrence after surgery
Time frame: Up to 5 years
Mortality rate
Death caused by operation or complications
Time frame: Up to 5 years
Overall survival
From grouping to any cause of death
Time frame: Up to 5 years
Operation time
Time of the surgical operation
Time frame: 1 week
Length of stay
The time of the patients in hospital
Time frame: 1 month
Complication rate
The incidence rate of postoperative complications in the two groups
Time frame: 1 month
Chronic Pain Score
Visual analogue score (VAS-score) is to asses the development of chronic pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 6 months after operation.
Time frame: 6 months
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