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

NCT ID: NCT01893333

Last Updated: 2017-05-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Group Type EXPERIMENTAL

Nerve sparing radical hysterectomy

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Nerve sparing radical hysterectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joo-Hyun Nam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joo-Hyun Nam, M.D., Ph.D.

Role: CONTACT

82-2-3010-3633

Facility Contacts

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Joo-Hyun Nam, M.D., Ph.D.

Role: primary

82-2-3010-3633

Other Identifiers

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NSRH_Cxca

Identifier Type: -

Identifier Source: org_study_id

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