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

Sponsor

Chen Chunlin (Other)

Overall Status

Unknown status

CT.gov ID

NCT03069040

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Procedure: nerve sparing radical hysterectomy Procedure: radical hysterectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Dec 31, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Abdominal pressure urination [3 months after operation]
Urine flow dynamic test results
Abdominal pressure urination [6 months after operation]
Urine flow dynamic test results
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]
the results of anorectal dynamics

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Medical Universtity, China	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Chen Chunlin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Chunlin, Obstetrics and Gynecology, Southern Medical University, China

ClinicalTrials.gov Identifier:

NCT03069040

Other Study ID Numbers:

SNSRH001

First Posted:

Mar 3, 2017

Last Update Posted:

Mar 3, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chen Chunlin, Obstetrics and Gynecology, Southern Medical University, China

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Mar 3, 2017