Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
Recruiting now · Not applicable
Conditions studied: Cervical Cancer
In brief
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).
Key facts
- Study ID
- NCT04929769
- Run by
- Obstetrics & Gynecology Hospital of Fudan University
- People needed
- 780
- Starts
- 2021-05-07
- Expected to finish
- 2026-09-07
- Last updated by the study team
- 2021-11-01
Who can join
Age: 21 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
- Age ≥ 21 years and ≤ 70 years.
- Surgery type B and C (refer to Q-M surgical staging)
- 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.
- No history of other malignancies.
- Non-pregnancy.
- Physical strength classification: Karnofsky score ≥ 60;
- Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
- 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)
You may not qualify if…
- Those who are contraindicated for various surgeries and cannot undergo surgery.
- Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
- Patients with recurrent cervical cancer
- Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.
Where it is running
- The Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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