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NCT Number: NCT04223466

Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure

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.

Recruiting

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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(+).

Treatment and study plan

Subxiphoid surgery procedure

Procedure

Subxiphoid procedure for thymectomy

VATS surgery procedure

Procedure

VATS procedure for thymectomy

Primary outcomes

  1. Visual Analogue Scale of postoperative pain

    Time frame: within 3 days

    in score

  2. Operation time

    Time frame: one day

    in minutes

  3. The amount of blood loss

    Time frame: one day

    in milliliter

  4. Duration of drainage

    Time frame: with 7 days

    in days

  5. Duration of hospital stay

    Time frame: with 7 days

    in days

Secondary outcomes

  1. Complete remission rates

    Time frame: 5 years

    Complete remission rates after 5 year follow-up of thymectomy for myasthenia gravis

  2. Recurrence rate

    Time frame: 5 years

    Recurrence rate after 5 year follow-up of thymectomy for thymoma

  3. Overall survival

    Time frame: within 10 years

    Overall survival in rate

Study contacts

Contact information is provided by the study sponsor or research team.

Yunpeng Zhao

CONTACT

[email protected]

+8618766188692

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Jan 10, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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