Actively Recruiting
Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short-Term and Long-Term Results
Led by The Second Hospital of Shandong University · Updated on 2022-11-16
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for thymectomy, a surgery to remove the thymus gland often performed for thymoma and myasthenia gravis. The study aims to evaluate the short-term and long-term outcomes of the newer subxiphoid procedure versus the conventional video-assisted thoracoscopic surgery (VATS) thymectomy. This comparison is important because thymectomy techniques have become less invasive recently, potentially improving recovery and long-term results. Participants will receive either the subxiphoid surgery procedure or the VATS surgery procedure for thymectomy. These two groups represent the experimental and active comparator arms of the study, respectively. The study is randomized and double-blind, meaning participants are randomly assigned to one of the two surgical methods without knowing which they receive. During the study, researchers will monitor several short-term outcomes, including postoperative pain using a visual analogue scale within 3 days, operation time, blood loss, drainage duration within 7 days, and hospital stay length within 7 days. They will also assess long-term outcomes such as complete remission rates and recurrence rates over 5 years, and overall survival within 10 years. Participant health and recovery will be closely followed throughout these periods.
CONDITIONS
Brief Title
Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 20 and 80 years
- Diagnosed with thymoma with or without myasthenia gravis
- Diagnosed with generalized myasthenia gravis not responding to conservative medicine treatment
- Good cardiopulmonary function
You will not qualify if you...
- Cardiopulmonary function that cannot tolerate surgery
- Generalized myasthenia gravis with MuSK positive status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 days
Participants undergo either a Subxiphoid or VATS thymectomy surgery and receive immediate post-operative care.
1 hospital stay including surgery and daily post-operative assessments
Trial Site Locations
Total: 1 location
1
Yunpeng
Jinan, Shandong, China, 250033
Actively Recruiting
Research Team
Y
Yunpeng Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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