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临床试验/NCT03069040
NCT03069040Unknown不适用

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

Chen Chunlin1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Abdominal pressure urination

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Cervical Cancer FIGO(2009) IA2,IB1,IB2,IIA1,IIA2

排除标准

  • Cervical Cancer FIGO(2009) > IIb
  • Patients received radiotherapy before opration
  • The patient refused to sign a consent form.

结局指标

主要结局

Abdominal pressure urination

时间窗: 1 years after operation

Urine flow dynamic test results

Survival rates

时间窗: 5 years after operation

Live or die

The recurrence rate

时间窗: 5 years after operation

Whether the tumor recurrence

次要结局

  • Abdominal pressure urination(6 months after operation)
  • the results of anorectal dynamics(6 months after opration)

研究者

发起方
Chen Chunlin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chen Chunlin

Obstetrics and Gynecology

Southern Medical University, China

研究点 (1)

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