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Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis

NCT04158661 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 248

Last updated 2021-09-24

No results posted yet for this study

Summary

The aim of this study is to investigate whether minimally invasive thymectomy achieves comparable efficacy and safety results compared to open thymectomy in patients with myasthenia gravis. The planned investigation is a multicenter observational study based on retrospective (present patient data) and prospective data (questionable outcome data).

Primary hypothesis: Minimally invasive thymectomy is not inferior to open thymectomy in terms of efficacy and safety (non-inferiority study).

Conditions

Interventions

PROCEDURE

thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)

preferring one unilateral access and placing three trocars between 3rd and 5th intercostal space in a triangular configuration, with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).

PROCEDURE

thymectomy by means of median sternotomy (transsternal)

with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).

PROCEDURE

no thymectomy (control)

routine medical care

Sponsors & Collaborators

  • NeuroCure Clinical Research Center, Charite, Berlin

    collaborator OTHER

  • Department of Surgery, Charite, Berlin

    collaborator UNKNOWN

  • Sana Klinikum Lichtenberg, Berlin

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Andreas Meisel, Prof. Dr. med. · Charité University, Berlin, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2020-11-30
Completion
2022-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158661 on ClinicalTrials.gov