Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1 IB2 IIA1)

  • STATUS
    Recruiting
  • End date
    Sep 7, 2026
  • participants needed
    780
  • sponsor
    Obstetrics & Gynecology Hospital of Fudan University
Updated on 9 November 2021
hysterectomy
carcinoma
adenocarcinoma
pet/ct scan

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).

Description

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:

  1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
  2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
  3. To assess postoperative complications and quality of survival.

Details
Condition cervix cancer, Cervical Cancer, cancer of the cervix, carcinoma of the cervix, carcinoma of cervix, Disorders of cervix NOS, cervical cancer, uterine, Uterine Serous Carcinoma, Uterine Cancer, cervical carcinoma, carcinoma of the cervix uteri
Treatment Total Abdominal Radical Hysterectomy, Total Laparoscopic or Robotic Radical Hysterectomy
Clinical Study IdentifierNCT04929769
SponsorObstetrics & Gynecology Hospital of Fudan University
Last Modified on9 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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