A Phase III Randomized Clinical Trial of Laparoscopic or Robotic RH using cancer cell spillage minimizing techniques vs Abdominal RH In Patients with Early-Stage Cervical Cancer

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0008661

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: 452

Inclusion Criteria

1) Patients aged 20-80 years
2) Histologically confirmed adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix
3) Patients who qualify for 2018 FIGO IA2 or IB1-2
4) Patients undergoing type II or III radical hysterectomy (Piver Classification)
5) Patients with adequate bone marrow, kidney and liver function
? WBC = 3,000/mm3
? Platelets = 100,000/mm3
? Creatinine = 2.0 mg/dL
? Bilirubin = 1.5 x institutional upper limit normal
? SGOT, SGPT, and ALP = 3 x institutional upper limit normal
6) Performance status of ECOG 0-1
7) Patients who voluntarily signed the research subject consent form

Exclusion Criteria

1) Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma of the cervix
2) Tumor size greater than 4 cm on imaging examination
3) FIGO stage II-IV
4) Patients with a history of pelvic or abdominal radiation therapy
5) Patients with evidence of metastatic disease on preoperative imaging, enlarged pelvic or aortic lymph nodes > 1.5 cm; or histologically positive lymph nodes
6) If you are unable to determine whether to consent yourself
7) Patients with serious underlying diseases or complications
8) Women who are pregnant or lactating
9) Neoadjuvant chemotherapy or preoperative radiation therapy
10) Patients who have had cancer other than non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder within 5 years or have received cancer treatment

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year disease-free survival (5-year DFS)

Secondary Outcome Measures

Name	Time	Method
3-year progression free survival ;5-year overall survival ;Surgery-related complications within 1 month after surgery, readmission rate, reoperation rate, mortality rate;Comparison of patients' quality of life after surgery