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Recruiting NCT04223466

Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

No phase Interventional Thymectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Subxiphoid surgery procedure, VATS surgery procedure.
Who it may be relevant to
Registry conditions: Thymectomy. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results

Overview

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.

Interventions

  • Procedure Subxiphoid surgery procedure
    Subxiphoid procedure for thymectomy
  • Procedure VATS surgery procedure
    VATS procedure for thymectomy

Primary outcome measures

  • Visual Analogue Scale of postoperative pain [Time frame: within 3 days]
  • Operation time [Time frame: one day]
  • The amount of blood loss [Time frame: one day]
  • Duration of drainage [Time frame: with 7 days]
  • Duration of hospital stay [Time frame: with 7 days]
Secondary outcome measures (3)
  • Complete remission rates [Time frame: 5 years]
  • Recurrence rate [Time frame: 5 years]
  • Overall survival [Time frame: within 10 years]

Eligibility criteria

Inclusion criteria

  • Thymoma with or without myasthenia gravis;
  • Generalized myasthenia gravis not sensitive to conservative medicine treatment;
  • Good cardiopulmonary function.

Exclusion criteria

  • Cardiopulmonary function can't bear surgery;
  • Generalized myasthenia gravis with MuSK(+).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Yunpeng — Jinan

Identifiers

NCT: NCT04223466 · Subxiphoid ZYP1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗