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).
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.
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.
Parallel
Total Laparoscopic or Robotic Radical Hysterectomy
Other interventionRadical 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.
Total Abdominal Radical Hysterectomy
Other interventionRadical 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.
the rate of OS at 5 years
Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)
the rate of PFS at 5 years
The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.
Analysis of continuous outcomes
Compare these between groups(The continuous outcomes include operative duration(min), anesthesia time(min), blood loss during operation(ml), postoperative pain score and postoperative hospital stay(day). The outcomes with normal distribution will be summarised using mean and standard deviation (SD), while the outcomes with non-normal distribution will be summarised using median and interquartile. The differences in the outcomes and 95% CIs will be analysed by generalised linear model (GLM) with treatment as fixed effect and with normal distribution and identity link function.)
Analysis of binary outcomes
Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event. The differences in the outcomes and 95% CIs will be analysed by GLM with treatment as fixed effect and with binomial distribution and identity link function.)
Safety analysis
Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups.
Click on the lead sponsor to view all of their trials.
Obstetrics & Gynecology Hospital of Fudan University
Lead sponsor
Children's Hospital of Fudan University
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Zhongshan Hospital
Collaborator
RenJi Hospital
Collaborator
Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
