Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure
ConditionThymectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorThe Second Hospital of Shandong University
About this trial
Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Thymoma with or without myasthenia gravis；
Generalized myasthenia gravis not sensitive to conservative medicine treatment;
Good cardiopulmonary function.
Disqualifiers
Cardiopulmonary function can't bear surgery;
Generalized myasthenia gravis with MuSK(+).
Trial design
Design model
Parallel
Treatments tested in this trial
Subxiphoid surgery procedure
Procedure/SurgerySubxiphoid procedure for thymectomy
VATS surgery procedure
Procedure/SurgeryVATS procedure for thymectomy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Subxiphoid groupExperimental treatment 1 intervention
Group B: VATS groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Scale of postoperative pain
in score
Time frame
within 3 days2
Operation time
in minutes
Time frame
one day3
The amount of blood loss
in milliliter
Time frame
one day4
Duration of drainage
in days
Time frame
with 7 daysSecondary outcomes
1
Complete remission rates
Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis
Time frame
5 years2
Recurrence rate
Recurrence rate after 5 year follow-up of thymectomy for thymoma
Time frame
5 years3
Overall survival
Overall survival in rate
Time frame
within 10 yearsSponsors and contacts
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Source ClinicalTrials.gov