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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03069040
• Other study ID #: SNSRH001
• Status: Active, not recruiting
• Phase: N/A
• First received: February 27, 2017
• Last updated: March 1, 2017
• Start date: November 1, 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2017
• Source: Southern Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• nerve sparing radical hysterectomy
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 .
• radical hysterectomy
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.

Locations

Country	Name	City	State
China	Southern Medical Universtity, China	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chen Chunlin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rates	Live or die	5 years after operation
Primary	The recurrence rate	Whether the tumor recurrence	5 years after operation
Primary	Abdominal pressure urination	Urine flow dynamic test results	1 years after operation
Secondary	Abdominal pressure urination	Urine flow dynamic test results	3 months after operation
Secondary	Abdominal pressure urination	Urine flow dynamic test results	6 months after operation
Secondary	the results of anorectal dynamics	the results of anorectal dynamics	1 months after opration
Secondary	the results of anorectal dynamics	the results of anorectal dynamics	3 months after opration
Secondary	the results of anorectal dynamics	the results of anorectal dynamics	6 months after opration