CompletedNot Applicable

Surgery for Masaoka-Koga I-II Thymoma

China101 participantsStarted 2021-08-15

Plain-language summary

The purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for Masaoka-Koga I-II thymoma.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
✓. The patients whose tumor diameter was \<6 cm;
✓. The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months;
✓. ASA grade：1-2;
✓. The patients should have no functional disorders in main organs.;
✓. The patients should be able to understand our research and sign the informed consent.

Exclusion criteria

✕. Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis;
✕. Patients with myasthenia gravis;
✕. Patients had undergone a sternotomy;
✕. The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control;
✕. The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy;
✕. Female who is positive for serum pregnancy test or during lactation period;
✕. The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation;
✕. The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders;

What they're measuring

Dosage of analgesic medication after surgery

Timeframe: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days

Visual Analog Scales scores for postoperative pain

Timeframe: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days

Postoperative hospital stay

Timeframe: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month

Trial details

NCT IDNCT05001113

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-15

View on ClinicalTrials.gov More Thymoma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
✓. The patients whose tumor diameter was \<6 cm;
✓. The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months;
✓. ASA grade：1-2;
✓. The patients should have no functional disorders in main organs.;
✓. The patients should be able to understand our research and sign the informed consent.

Exclusion criteria

✕. Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis;
✕. Patients with myasthenia gravis;
✕. Patients had undergone a sternotomy;
✕. The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control;
✕. The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy;
✕. Female who is positive for serum pregnancy test or during lactation period;
✕. The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation;
✕. The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders;

What they're measuring

Dosage of analgesic medication after surgery

Timeframe: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days

Visual Analog Scales scores for postoperative pain

Timeframe: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days

Postoperative hospital stay

Timeframe: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month