Radical hysterectomy and pelvic lymph node dissection (+/- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. And minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. This study aims to compare total laparoscopic radical hysterectomy and total abdominal radical hysterectomy in terms of disease-free survival and overall survival. Rates and characteristics of recurrence, incidence of complications and morbidity, impact on quality of life and cost-effectiveness will also be determined.
Patients with histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
Patients with histologically confirmed stage IAI (+) LVSI, IA2, IB1, IB2 and IIA1 disease (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
Patients undergoing a Type II/Type III radical hysterectomy (Piver-Rutledge Classification) or Type B/Type C radical hysterectomy (Querleu-Morrow Classification)
Patients with adequate bone marrow, renal and hepatic function using Standard International Units 4.1 WBC > 3.0 x 109 cells/L 4.2 Platelets > 100 x 109 cells/L 4.3 Creatinine < 2.0 mg/dL 4.4 Bilirubin < 1.5 x upper normal limit and AST/SGOT or ALT/SGPT < 3 x upper normal limit
Patients with any histology other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
Stage IB3, IIA2-IV (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
Patients with evidence of metastatic disease by conventional imaging studies (CT Scan, MRI or PET CT Scan), enlarged pelvic or aortic lymph nodes > 2cm, or histologically positive lymph nodes
Patients with a history of pelvic or abdominal radiotherapy
Parallel
radical hysterectomy
Procedure/SurgeryTo compare disease-free survival and overall survival of patients with early stage cervical cancer undergoing total laparoscopic radical hysterectomy versus total abdominal radical hysterectomy
Disease-Free Survival
the time from randomization to disease recurrence or death from cervical cancer
Overall Survival
the time from randomization to disease recurrence or death from any cause
Recurrence Pattern
Recurrences will be described in detail and recorded according to date and location of first recurrence. The location can be designated as local, vault, pelvis or distal metastasis.
Intraoperative and Postoperative Complications
* Intraoperative complications - hemorrhage; injury to bladder, ureter, bowel; vascular injury; nerve injury * Perioperative complications (from post-surgery to discharge from hospital) - genitourinary (urinary tract infection, urinary retention), gastrointestinal (ileus), cardiac (myocardial infarction, atrial fibrillation), pulmonary (edema, atelectasis, pneumonia), renal and cerebrovascular morbidity. Wound and vault complications (infection, breakdown and dehiscence). Septicemia and thromboembolic complications (deep vein thrombosis and pulmonary embolism). Lymphocyst and abscess formation. * Early postoperative complications (\<4 weeks from surgery): Wound and vault complications (infection, dehiscence). Urinary retention, urinary incontinence. Lymphocyst, lymphedema, abscess formation, or fistula formation. * Long term morbidity (4 weeks to 12 months from surgery): Urinary retention, urinary incontinence. lymphedema, incisional hernia formation, vaginal evisceration.
Impact on Quality of Life
Change in quality of life using Functional Assessment of Cancer Therapy Cervical (FACT-Cx) between baseline (pre-surgery) and 6 months after surgery. The FACT-CX comprises 42 items with 5 domains and a score range of 0-168.
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