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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03069040
Enrollment
50
Registered
2017-03-03
Start date
2011-11-01
Completion date
2017-12-31
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

cervical cancer, NSRH, RH, urine flow mechanics, anorectal dynamics

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.

Interventions

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 .

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.

Sponsors

Chen Chunlin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Survival rates5 years after operationLive or die
The recurrence rate5 years after operationWhether the tumor recurrence
Abdominal pressure urination1 years after operationUrine flow dynamic test results

Secondary

MeasureTime frameDescription
Abdominal pressure urination3 months after operationUrine flow dynamic test results
the results of anorectal dynamics1 months after oprationthe results of anorectal dynamics

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026