Cervical CancerNSRHCXCANCT01893333
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
A study testing Nerve sparing radical hysterectomy in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Nerve sparing radical hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
Joo-Hyun Nam, M.D., Ph.D., 82-2-3010-3633, jhnam@amc.seoul.kr
About this study
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.
- Conditions
- Cervical Cancer
- Being tested
- Nerve sparing radical hysterectomy
- Keywords
- cervical cancer, nerve sparing radical hysterectomy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve sparing radical hysterectomyProcedure or surgery
Nerve sparing radical hysterectomy
- sparing hypogastric nerve
- sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament
- sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve
| Study group | Role | What they receive |
|---|---|---|
| Nerve sparing radical hysterectomy group | Experimental | 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 Receives: Procedure: Nerve sparing radical hysterectomy |
| Radical hysterectomy group | Active comparator | Conventional radical hysterectomy Receives: Procedure: Nerve sparing radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bladder dysfunction after surgery
Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL
Measured: 5 days after the surgery
Secondary outcomes (12)
rectal & anal function after surgery
Measured: 6, 12 months after surgery
Sexual function
Measured: 6, 12 months after surgery
Quality of life
Measured: 6, 12 months after surgery
operative time
Measured: immediately after surgery
amount of bleeding in operation
Measured: immediately after surgery
frequency of blood transfusion
Measured: within 1 week after surgery
amount of blood transfusion
Measured: within 1 week after surgery
postoperative complication
Measured: within 1 month after surgery
time from surgery to return to work
Measured: within 1 month after surgery
management cost
Measured: within 1 week after surgery
size of resected parametrial tissue
Measured: immediately after surgery
2year disease free survival
Measured: 2 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
- Investigators
- Joo-Hyun Nam, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893333
- Sponsor's protocol ID
- NSRH_Cxca
- Acronym
- NSRHCXCA
- Status last verified
- May 2017
- First submitted
- 10 Jun 2013
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
- ClinicalTrials.gov ID
- NCT01893333
- Acronym / sponsor ID
- NSRHCXCA / NSRH_Cxca
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, nerve sparing radical hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve sparing radical hysterectomy group | Experimental | Procedure: Nerve sparing radical hysterectomy1. 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 | Active comparator | Procedure: Nerve sparing radical hysterectomyConventional radical hysterectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve sparing radical hysterectomyNerve 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 | Procedure or surgery | Nerve sparing radical hysterectomy group, Radical hysterectomy group |
Primary outcome
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
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Hyun Nam, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve sparing radical hysterectomy in people with Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joo-Hyun Nam, M.D., Ph.D. (82-2-3010-3633, jhnam@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bladder dysfunction after surgery (time frame: 5 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.