The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer (NSRHCXCA)
May 27, 2017 updated by: Joo-Hyun Nam, Asan Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
146
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 138-736
- Recruiting
- Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nerve sparing radical hysterectomy group
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Nerve sparing radical hysterectomy
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Active Comparator: Radical hysterectomy group
Conventional radical hysterectomy
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Nerve sparing radical hysterectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 days after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rectal & anal function after surgery
Time Frame: 6, 12 months after surgery
|
6, 12 months after surgery
|
|
Sexual function
Time Frame: 6, 12 months after surgery
|
6, 12 months after surgery
|
|
Quality of life
Time Frame: 6, 12 months after surgery
|
6, 12 months after surgery
|
|
operative time
Time Frame: immediately after surgery
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immediately after surgery
|
|
amount of bleeding in operation
Time Frame: immediately after surgery
|
immediately after surgery
|
|
frequency of blood transfusion
Time Frame: within 1 week after surgery
|
within 1 week after surgery
|
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amount of blood transfusion
Time Frame: within 1 week after surgery
|
within 1 week after surgery
|
|
postoperative complication
Time Frame: within 1 month after surgery
|
within 1 month after surgery
|
|
time from surgery to return to work
Time Frame: within 1 month after surgery
|
within 1 month after surgery
|
|
management cost
Time Frame: within 1 week after surgery
|
within 1 week after surgery
|
|
size of resected parametrial tissue
Time Frame: immediately after surgery
|
immediately after surgery
|
|
2year disease free survival
Time Frame: 2 year after treatment
|
2 year after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
July 2, 2013
First Posted (Estimate)
July 9, 2013
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 27, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSRH_Cxca
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.