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

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Procedure: nerve sparing radical hysterectomy; Procedure: radical hysterectomy

• Registration Number: NCT03069040
• Lead Sponsor: Chen Chunlin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-01
• Last Update Submitted: 2017-03-01
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nerve-sparing radical hysterectomy	nerve sparing radical hysterectomy	The patient recived surgury of nerve-sparing radical hysterectomy.
radical hysterectomy	radical hysterectomy	The patient recived surgury of radical hysterectomy.

Primary Outcome Measures

Name	Time	Method
Abdominal pressure urination	1 years after operation	Urine flow dynamic test results
Survival rates	5 years after operation	Live or die
The recurrence rate	5 years after operation	Whether the tumor recurrence

Secondary Outcome Measures

Name	Time	Method
Abdominal pressure urination	6 months after operation	Urine flow dynamic test results
the results of anorectal dynamics	6 months after opration	the results of anorectal dynamics

Trial Locations

Locations (1)

Southern Medical Universtity, China; 🇨🇳 Guangzhou, Guangdong, China