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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: nerve sparing radical hysterectomy; Procedure: radical hysterectomy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical Universtity, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nerve-sparing radical hysterectomy; The patient recived surgury of nerve-sparing radical hysterectomy.	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 .; Other Names: Type C1 radical hysterectomy
Active Comparator: radical hysterectomy; The patient recived surgury of radical hysterectomy.	Procedure: 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.; Other Names: Type C2 radical hysterectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chen Chunlin

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: cervical cancer; RH; NSRH; urine flow mechanics; anorectal dynamics
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: SNSRH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No