Clinical trial NCT03069040: Nerve Sparing Radical Hysterectomy VS Radical Hysterectomy: Safety and Clinical Efficacy
Official title: The Randomized Controlled Trial of Nerve Sparing Hysterectomy Radical Hysterectomy and Radical Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
NSRH
RH
urine flow mechanics
anorectal dynamics
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival rates
timeFrame: 5 years after operation
measure: The recurrence rate
timeFrame: 5 years after operation
measure: Abdominal pressure urination
timeFrame: 1 years after operation
Secondary outcomes:
measure: Abdominal pressure urination
timeFrame: 3 months after operation
measure: Abdominal pressure urination
timeFrame: 6 months after operation
measure: the results of anorectal dynamics
timeFrame: 1 months after opration
measure: the results of anorectal dynamics
timeFrame: 3 months after opration
measure: the results of anorectal dynamics
timeFrame: 6 months after opration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical Universtity, China
state: Guangdong
Study officials:
References: