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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: Nerve sparing radical hysterectomy

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve sparing radical hysterectomy group; sparing hypogastric nerve; sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament; sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve	Procedure: Nerve sparing radical hysterectomy; Nerve sparing radical hysterectomy; sparing hypogastric nerve; sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament; sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve
Active Comparator: Radical hysterectomy group; Conventional radical hysterectomy	Procedure: Nerve sparing radical hysterectomy; Nerve sparing radical hysterectomy; sparing hypogastric nerve; sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament; sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bladder dysfunction after surgery	Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL	5 days after the surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
rectal & anal function after surgery	6, 12 months after surgery
Sexual function	6, 12 months after surgery
Quality of life	6, 12 months after surgery
operative time	immediately after surgery
amount of bleeding in operation	immediately after surgery
frequency of blood transfusion	within 1 week after surgery
amount of blood transfusion	within 1 week after surgery
postoperative complication	within 1 month after surgery
time from surgery to return to work	within 1 month after surgery
management cost	within 1 week after surgery
size of resected parametrial tissue	immediately after surgery
2year disease free survival	2 year after treatment

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 27, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cervical cancer; nerve sparing radical hysterectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: NSRH_Cxca