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

This study is currently recruiting participants.
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01893333
First Posted: July 9, 2013
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
  Purpose
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.

Condition Intervention
Cervical Cancer Procedure: Nerve sparing radical hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Joo-Hyun Nam, Asan Medical Center:

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


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

Estimated Enrollment: 146
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Procedure: 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
Active Comparator: Radical hysterectomy group
Conventional radical hysterectomy
Procedure: 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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893333


Contacts
Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633 jhnam@amc.seoul.kr

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.    82-2-3010-3633    jhnam@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01893333     History of Changes
Other Study ID Numbers: NSRH_Cxca
First Submitted: June 10, 2013
First Posted: July 9, 2013
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Joo-Hyun Nam, Asan Medical Center:
cervical cancer
nerve sparing radical hysterectomy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female