Nerve Sparing Radical Hysterectomy VS Radical Hysterectomy: Safety and Clinical Efficacy

Study Overview
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Brief Summary
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Cervical cancer in young patients increased significantly in recent years, and early surgical treatment for patients with 5 years of survival rate is as high as 90%, But the traditional extensive hysterectomy (RH) caused by intraoperative pelvic autonomic nerve may damage the bladder and rectum and the incidence of complications such as sexual dysfunction is nearly 25% to 80%, thus seriously affect the patient's quality of life.Pelvic autonomic nerve preservation system of extensive hysterectomy (NSRH) can decrease the complications of above, but at home and abroad mainly adopts pulling the urine tube time, determination methods of residual urine volume, bladder function are studied in only a few scholars urine flow mechanics method is applied to carry on objective appraisal limited cases of postoperative bladder function, and the anorectal function damage ，we can use the anorectal dynamics to get objective index of anorectal function .overall research lack of large sample research of dynamic system. No objective index to evaluate the anorectal function In the early stage of the study, we have conducted about uterine ligament, sacral ligaments and nerve distribution of the bladder cervix vaginal ligament of experimental research, provide the neural anatomy basis for NSRH operation, and based on research for innovative operation scheme is put forward.Proposed on the basis of the above research, this study adopt the internationally used - urine flow mechanics, the method for evaluating the bladder function of NSRH, RH, two kinds of the injured function of bladder surgery patients before and after operation of comparative study, the change of dynamic assessment before and after surgery in patients with bladder function,and the anorectal function dameage and than provide the basis for further treatment.

Official Title
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The Randomized Controlled Trial of Nerve Sparing Hysterectomy Radical Hysterectomy and Radical Hysterectomy

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: nerve sparing radical hysterectomy
* Procedure: radical hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical Cancer FIGO(2009) IA2,IB1,IB2,IIA1,IIA2 Exclusion Criteria: Cervical Cancer FIGO(2009) > IIb Patients received radiotherapy before opration The patient refused to sign a consent form.

Ages Eligible for Study
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Minimum Age: 20 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nerve-sparing radical hysterectomy<br>The patient recived surgury of nerve-sparing radical hysterectomy. | Procedure: nerve sparing radical hysterectomy<br>* Type C1 radical hysterectomy,that is nerve sparing radical hysterectomy, requires separation of two parts of the dorsal parametria: the medialpart , which entails recto -uterineandrecto-vaginal ligaments, and the lateral laminar structure, also called mesoureter, which contains the hypogastric plexus. Furthermore, type C1 requires only a partial dissection of the ureter from the ventral parametria, which is usually asymmetric towards more extensive resection of the medial leaf of the cranial (above the ureter) part of the ventral parametria .<br>* Other names: Type C1 radical hysterectomy;|
| Active Comparator: radical hysterectomy<br>The patient recived surgury of radical hysterectomy. | Procedure: radical hysterectomy<br>* In the C2 type, the ureter is completely dissected from the ventral parametria up to the urinary bladder wall. Defining the resection limits on the longitudinal (deep parametrial or vertical) plane is crucial for distinguishing between types C1 and C2.<br>* Other names: Type C2 radical hysterectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates | Live or die | 5 years after operation | 
| The recurrence rate | Whether the tumor recurrence | 5 years after operation | 
| Abdominal pressure urination | Urine flow dynamic test results | 1 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pressure urination | Urine flow dynamic test results | 3 months after operation | 
| Abdominal pressure urination | Urine flow dynamic test results | 6 months after operation | 
| the results of anorectal dynamics | the results of anorectal dynamics | 1 months after opration | 
| the results of anorectal dynamics | the results of anorectal dynamics | 3 months after opration | 
| the results of anorectal dynamics | the results of anorectal dynamics | 6 months after opration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RH, cervical cancer, NSRH, urine flow mechanics, anorectal dynamics