The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
NCT ID: NCT01893333
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
146 participants
INTERVENTIONAL
2013-03-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Nerve sparing radical hysterectomy group
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
Nerve sparing radical hysterectomy
Nerve sparing radical hysterectomy
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
Radical hysterectomy group
Conventional radical hysterectomy
Nerve sparing radical hysterectomy
Nerve sparing radical hysterectomy
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
Interventions
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Nerve sparing radical hysterectomy
Nerve sparing radical hysterectomy
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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Joo-Hyun Nam
Professor
Principal Investigators
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Joo-Hyun Nam, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSRH_Cxca
Identifier Type: -
Identifier Source: org_study_id
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