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

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nerve sparing radical hysterectomy
radical hysterectomy
Sponsored by
Chen Chunlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, NSRH, RH, urine flow mechanics, anorectal dynamics

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Southern Medical Universtity, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nerve-sparing radical hysterectomy

radical hysterectomy

Arm Description

The patient recived surgury of nerve-sparing radical hysterectomy.

The patient recived surgury of radical hysterectomy.

Outcomes

Primary Outcome Measures

Survival rates
Live or die
The recurrence rate
Whether the tumor recurrence
Abdominal pressure urination
Urine flow dynamic test results

Secondary Outcome Measures

Abdominal pressure urination
Urine flow dynamic test results
Abdominal pressure urination
Urine flow dynamic test results
the results of anorectal dynamics
the results of anorectal dynamics
the results of anorectal dynamics
the results of anorectal dynamics
the results of anorectal dynamics
the results of anorectal dynamics

Full Information

First Posted
February 27, 2017
Last Updated
March 1, 2017
Sponsor
Chen Chunlin
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1. Study Identification

Unique Protocol Identification Number
NCT03069040
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2011 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chen Chunlin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer, NSRH, RH, urine flow mechanics, anorectal dynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nerve-sparing radical hysterectomy
Arm Type
Experimental
Arm Description
The patient recived surgury of nerve-sparing radical hysterectomy.
Arm Title
radical hysterectomy
Arm Type
Active Comparator
Arm Description
The patient recived surgury of radical hysterectomy.
Intervention Type
Procedure
Intervention Name(s)
nerve sparing radical hysterectomy
Other Intervention Name(s)
Type C1 radical hysterectomy
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
radical hysterectomy
Other Intervention Name(s)
Type C2 radical hysterectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival rates
Description
Live or die
Time Frame
5 years after operation
Title
The recurrence rate
Description
Whether the tumor recurrence
Time Frame
5 years after operation
Title
Abdominal pressure urination
Description
Urine flow dynamic test results
Time Frame
1 years after operation
Secondary Outcome Measure Information:
Title
Abdominal pressure urination
Description
Urine flow dynamic test results
Time Frame
3 months after operation
Title
Abdominal pressure urination
Description
Urine flow dynamic test results
Time Frame
6 months after operation
Title
the results of anorectal dynamics
Description
the results of anorectal dynamics
Time Frame
1 months after opration
Title
the results of anorectal dynamics
Description
the results of anorectal dynamics
Time Frame
3 months after opration
Title
the results of anorectal dynamics
Description
the results of anorectal dynamics
Time Frame
6 months after opration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Southern Medical Universtity, China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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