Gynecologic CancerNCT01679483
Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
A study testing FloSeal application in people with Gynecologic Cancer and Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Cervical Cancer, Endometrial Cancer
- What is being tested?
- FloSeal application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Nov 2015
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
- FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
- Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
- Patients with adequate bone marrow, renal and hepatic function:
- WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal
- American Society of Anesthesiology Physical Status 0-1
Show all 9Show fewer
- Performance status of ECOG 0-2
- Patient must be suitable candidates for surgery
- Patients who have signed an approved Informed Consent
Who cannot join
- Patients with a history of pelvic or abdominal radiotherapy;
- Patients who are pregnant
- Patients with contraindications to surgery;
- Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patient's compliance and geographic proximity that do not allow adequate follow-up.
- Patients who undergo only lymph node sampling
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
Official title: THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
- Conditions
- Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tubal Cancer
- Being tested
- FloSeal application
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloSeal applicationDrug
At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
| Study group | Role | What they receive |
|---|---|---|
| FloSeal group | Experimental | This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area. Receives: Drug: FloSeal application |
| No FloSeal group | No intervention | All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lymphocele an lymphatic ascites
Measured: within 1 year after surgery
Secondary outcomes (7)
Time interval from surgery to removal of closed drain system
Measured: with 2 weeks after surgery
Postoperative drain amount
Measured: with 2 weeks after surgery
Postoperative hospital stay
Measured: within 2 weeks after surgery
Postoperative bleeding incidence
Measured: within 2 weeks after surgery
Postoperative complication incidence
Measured: within 1 month after surgery
Quality of life
Measured: within 1 year after surgery
2-year disease free survival and overall survival
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- 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
- NCT01679483
- Sponsor's protocol ID
- FloSeal-LND
- Status last verified
- May 2017
- First submitted
- 3 Sep 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
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 ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01679483
- Acronym / sponsor ID
- FloSeal-LND
- Conditions
- Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tubal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Sep 2012 (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 compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FloSeal group | Experimental | Drug: FloSeal applicationThis group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area. |
| No FloSeal group | No intervention | –All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
- FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
- Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
- Patients with adequate bone marrow, renal and hepatic function:
- WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal
Key exclusion criteria (6 listed)
- Patients with a history of pelvic or abdominal radiotherapy;
- Patients who are pregnant
- Patients with contraindications to surgery;
- Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patient's compliance and geographic proximity that do not allow adequate follow-up.
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 |
|---|---|---|
| FloSeal applicationAt the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area. | Drug | FloSeal group |
Primary outcome
Incidence of lymphocele an lymphatic ascites
Time frame: within 1 year after surgery
7 secondary outcomes
Time interval from surgery to removal of closed drain system
Time frame: with 2 weeks after surgery
Postoperative drain amount
Time frame: with 2 weeks after surgery
Postoperative hospital stay
Time frame: within 2 weeks after surgery
Postoperative bleeding incidence
Time frame: within 2 weeks after surgery
Postoperative complication incidence
Time frame: within 1 month after surgery
Quality of life
Time frame: within 1 year after surgery
2-year disease free survival and overall survival
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 FloSeal application in people with Gynecologic Cancer and 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 9 inclusion and 6 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of lymphocele an lymphatic ascites (time frame: within 1 year after 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; AzTrials last refreshed its copy on 8 Nov 2026.