Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID04223466

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

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

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

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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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