Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
Obstetrics & Gynecology Hospital of Fudan University
1,104 participants
May 12, 2021
INTERVENTIONAL
Conditions
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 IB3, IIA2).
Eligibility
Inclusion Criteria9
- Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
- 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)
Exclusion Criteria4
- 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.
Interventions
Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
Locations(1)
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NCT04939831