The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer (NSRHCXCA)

Asan Medical Center

Status: Unknown

Conditions: Cervical Cancer

Treatments: Procedure: Nerve sparing radical hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01893333

NSRH_Cxca

Details and patient eligibility

About

To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologically diagnosed cervical cancer
• FIGO stage IA2-IIA
• Diameter of tumor is less than 4cm on exam
• One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
• Age between 18-70
• Performance status; GOG 0-1
• Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase < normal X 3
• Patient with informed consent

Exclusion creteria:

• Small cell carcinoma
• Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases
• Prior chemotherapy or radiotherapy
• Severe bladder funtion abnormality
• Double primary malignant tumor
• Psychiatric problems
• Pregnant or breast feeding status
• Legally unable to participate clinical trial
• When there is a Doctor's decision that patient is unable to participate clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

146 participants in 2 patient groups

Nerve sparing radical hysterectomy group

Experimental group

Description:

1. sparing hypogastric nerve 2. sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament 3. sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve

Treatment:

Procedure: Nerve sparing radical hysterectomy

Radical hysterectomy group

Active Comparator group

Description:

Conventional radical hysterectomy

Treatment:

Procedure: Nerve sparing radical hysterectomy