The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical cancer, nerve sparing radical hysterectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Nerve sparing radical hysterectomy
Type: Procedure
Overall Status
Recruiting
Summary
To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically diagnosed cervical cancer

- FIGO stage IA2-IIA

- Diameter of tumor is less than 4cm on exam

- One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma

- Age between 18-70

- Performance status; GOG 0-1

- Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase < normal X 3

- Patient with informed consent

Exclusion creteria:

- Small cell carcinoma

- Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases

- Prior chemotherapy or radiotherapy

- Severe bladder funtion abnormality

- Double primary malignant tumor

- Psychiatric problems

- Pregnant or breast feeding status

- Legally unable to participate clinical trial

- When there is a Doctor's decision that patient is unable to participate clinical trial
Location
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam, M.D., Ph.D. - 82-2-3010-3633 - jhnam@amc.seoul.kr
Start Date
March 2013
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page