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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-70
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Total Laparoscopic or Robotic Radical Hysterectomy
  • Total Abdominal Radical Hysterectomy

Treatment groups

780 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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