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

Cervical Cancer Clinical Trial

— NSRHCXCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01893333
• Other study ID #: NSRH_Cxca
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2013
• Last updated: May 27, 2017
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: Joo-Hyun Nam, M.D., Ph.D.
• Phone: 82-2-3010-3633
• Email: jhnam[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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