The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Nerve sparing radical hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve sparing radical hysterectomy group<br>sparing hypogastric nerve sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve | Procedure: Nerve sparing radical hysterectomy<br>* Nerve sparing radical hysterectomy sparing hypogastric nerve sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve<br>|
| Active Comparator: Radical hysterectomy group<br>Conventional radical hysterectomy | Procedure: Nerve sparing radical hysterectomy<br>* Nerve sparing radical hysterectomy sparing hypogastric nerve sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bladder dysfunction after surgery | Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL | 5 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, nerve sparing radical hysterectomy