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

C

Chen Chunlin

Status

Unknown

Conditions

Cervical Cancer

Treatments

Procedure: nerve sparing radical hysterectomy
Procedure: radical hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03069040
SNSRH001

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

nerve-sparing radical hysterectomy
Experimental group
Description:
The patient recived surgury of nerve-sparing radical hysterectomy.
Treatment:
Procedure: nerve sparing radical hysterectomy
radical hysterectomy
Active Comparator group
Description:
The patient recived surgury of radical hysterectomy.
Treatment:
Procedure: radical hysterectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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