NCT04929769 Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
| NCT ID | NCT04929769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Obstetrics & Gynecology Hospital of Fudan University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 780 participants |
| Start Date | 2021-05-07 |
| Primary Completion | 2024-09-07 |
Trial Parameters
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Brief Summary
The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).
Eligibility Criteria
Inclusion Criteria: 1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1). 2. Age ≥ 21 years and ≤ 70 years. 3. Surgery type B and C (refer to Q-M surgical staging) 4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin \> 60g/L Platelets \> 70\*109/L Leukocytes \> 3\*109/L Creatinine \< 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. No history of other malignancies. 6. Non-pregnancy. 7. Physical strength classification: Karnofsky score ≥ 60; 8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI) Exclu
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