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

NCT03069040 | Unknown DMC

• 1 other identifier: SNSRH001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Abdominal pressure urination

  3 months after operation

• Abdominal pressure urination

  6 months after operation

• the results of anorectal dynamics

  1 months after opration

• the results of anorectal dynamics

  3 months after opration

• the results of anorectal dynamics

  6 months after opration

Study Arms (2)

nerve-sparing radical hysterectomy

EXPERIMENTAL

The patient recived surgury of nerve-sparing radical hysterectomy.

Procedure: nerve sparing radical hysterectomy

radical hysterectomy

ACTIVE COMPARATOR

The patient recived surgury of radical hysterectomy.

Procedure: radical hysterectomy

Interventions

nerve sparing radical hysterectomy PROCEDURE

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 .

Also known as: Type C1 radical hysterectomy

nerve-sparing radical hysterectomy

radical hysterectomy PROCEDURE

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.

Also known as: Type C2 radical hysterectomy

radical hysterectomy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical Cancer FIGO(2009) IA2,IB1,IB2,IIA1,IIA2

You may not qualify if:

• Cervical Cancer FIGO(2009) \> IIb
• Patients received radiotherapy before opration
• The patient refused to sign a consent form.

Sponsors & Collaborators

• Chen Chunlin: lead

Study Sites (1)

Southern Medical Universtity, China

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 3, 2017
• Study Start: November 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)