Transsternal Versus Transcervical Thymectomy
- Conditions
- Myasthenia Gravis, Thymectomy
- Interventions
- Procedure: Transcervical ThymectomyProcedure: Transsternal Thymectomy
- Registration Number
- NCT03825185
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Brief Summary
Objective: To comparatively analyze long-term results and complications of transcervical (TCT) and transsternal thymectomy (TST) in a randomized controlled trial with a mean follow-up of ten years.
Results: Outcomes 10 years after surgery by MGFA post-intervention status showed that complete stable remission was achieved in 8 (21.6%) patients of the TCT group, and in 20 patients (55.5%) of the TST group.
Conclusions: Transcervical and transsternal thymectomy are safe and result in significant improvement of patients with Myasthenia Gravis. TST has superior results in terms of complete stable remission at 10 years.
- Detailed Description
Background: Thymectomy is an effective treatment for Myasthenia Gravis in the adult population. Surgical removal of the thymus can be performed through several approaches. Comparison of the most commonly used surgical techniques through randomized control trials with long-term follow-up is scarce.
Objective: To comparatively analyze long-term results and complications of transcervical (TCT) and transsternal thymectomy (TST) in a randomized controlled trial with a mean follow-up of ten years.
Results: A total of 100 patients were randomized to transsternal thymectomy (50), and transcervical procedure (50). There were not significant differences in the demographic characteristics, MGFA clinical classification, and MGFA therapy status between groups before surgery. Twenty patients were lost of follow up during the first year and were excluded. Our final group included 40 patients in each group. Three patients in TCT group (7.5%) and 6 patients in the TST group (15%) developed surgical complications. At 1 year of follow-up, 7 patients (17.5%) of the TCT group were asymptomatic in comparison with 15 patients (37.5%) of group TST, after 10 years of follow-up, 26 cases (72.9%) in group TCT were asymptomatic in comparison with 29 cases (80.5%) of group TST. Outcomes 10 years after surgery by MGFA post-intervention status showed that complete stable remission was achieved in 8 (21.6%) patients of the TCT group, and in 20 patients (55.5%) of the TST group.
Conclusions: Transcervical and transsternal thymectomy are safe and result in significant improvement of patients with Myasthenia Gravis. TST has superior results in terms of complete stable remission at 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion criteria were a clinical diagnosis of MG confirmed by biochemical or physiologic studies and a CT excluding thymoma. -
Exclusion criteria were contraindications for major surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcervical Thymectomy Transcervical Thymectomy 50 patients were randomized to transcervical thymectomy for treatment of myasthenia gravis. TranssternalThymectomy Transsternal Thymectomy 50 patients were randomized to transternal thymectomy for treatment of myasthenia gravis.
- Primary Outcome Measures
Name Time Method Pharmacological remission of MG. 10 years Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Clinical remission of MG. 10 years Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
Pharmacological and clinical remission of MG. 10 years Remission of MG classified according to MGFA Post intervention status for postoperative remission of Myasthenia Gravis
- Secondary Outcome Measures
Name Time Method