The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Not Applicable
- Conditions
- Cervical Cancer
- Interventions
- Procedure: Nerve sparing radical hysterectomy
- Registration Number
- NCT01893333
- Lead Sponsor
- Asan Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 146
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nerve sparing radical hysterectomy group 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 Radical hysterectomy group Nerve sparing radical hysterectomy Conventional radical hysterectomy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method rectal & anal function after surgery 6, 12 months after surgery 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 amount of blood transfusion within 1 week 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
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
🇰🇷Seoul, Korea, Republic of