Cervical Cancer
Conditions
Keywords
cervical cancer, nerve sparing radical hysterectomy
Brief 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.
Interventions
PROCEDURENerve sparing radical hysterectomy
Nerve sparing radical hysterectomy 1. sparing hypogastric nerve 2. sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament 3. sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bladder dysfunction after surgery | 5 days after the surgery | Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL |
Secondary
| Measure | Time frame |
|---|---|
| Sexual function | 6, 12 months after surgery |
| Quality of life | 6, 12 months after surgery |
| operative time | immediately after surgery |
| amount of bleeding in operation | immediately after surgery |
| frequency of blood transfusion | within 1 week after surgery |
| rectal & anal function after surgery | 6, 12 months after surgery |
| postoperative complication | within 1 month after surgery |
| time from surgery to return to work | within 1 month after surgery |
| management cost | within 1 week after surgery |
| size of resected parametrial tissue | immediately after surgery |
| 2year disease free survival | 2 year after treatment |
| amount of blood transfusion | within 1 week after surgery |
Countries
South Korea
Contacts
Primary ContactJoo-Hyun Nam, M.D., Ph.D.
Outcome results
None listed