Clinical trial NCT01893333: The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Official title: The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
nerve sparing radical hysterectomy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Incidence of bladder dysfunction after surgery
timeFrame: 5 days after the surgery
Secondary outcomes:
measure: rectal & anal function after surgery
timeFrame: 6, 12 months after surgery
measure: Sexual function
timeFrame: 6, 12 months after surgery
measure: Quality of life
timeFrame: 6, 12 months after surgery
measure: operative time
timeFrame: immediately after surgery
measure: amount of bleeding in operation
timeFrame: immediately after surgery
measure: frequency of blood transfusion
timeFrame: within 1 week after surgery
measure: amount of blood transfusion
timeFrame: within 1 week after surgery
measure: postoperative complication
timeFrame: within 1 month after surgery
measure: time from surgery to return to work
timeFrame: within 1 month after surgery
measure: management cost
timeFrame: within 1 week after surgery
measure: size of resected parametrial tissue
timeFrame: immediately after surgery
measure: 2year disease free survival
timeFrame: 2 year after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: