Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Asan Medical Center
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01679483
First received: September 3, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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Purpose
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
| Condition | Intervention |
|---|---|
|
Gynecologic Cancer Cervical Cancer Endometrial Cancer Ovarian Cancer Fallopian Tubal Cancer |
Drug: FloSeal application |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- Incidence of lymphocele an lymphatic ascites [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time interval from surgery to removal of closed drain system [ Time Frame: with 2 weeks after surgery ] [ Designated as safety issue: No ]
- Postoperative drain amount [ Time Frame: with 2 weeks after surgery ] [ Designated as safety issue: No ]
- Postoperative hospital stay [ Time Frame: within 2 weeks after surgery ] [ Designated as safety issue: No ]
- Postoperative bleeding incidence [ Time Frame: within 2 weeks after surgery ] [ Designated as safety issue: Yes ]
- Postoperative complication incidence [ Time Frame: within 1 month after surgery ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: No ]
- 2-year disease free survival and overall survival [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FloSeal group
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.
|
Drug: FloSeal application
At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
|
|
No Intervention: No FloSeal group
All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Performance status of ECOG 0-2
- Patient must be suitable candidates for surgery
- Patients who have signed an approved Informed Consent
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679483
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
Baxter Healthcare Corporation
Investigators
| Principal Investigator: | Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Joo-Hyun Nam, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01679483 History of Changes |
| Other Study ID Numbers: | FloSeal-LND |
| Study First Received: | September 3, 2012 |
| Last Updated: | September 3, 2012 |
| Health Authority: | Korea: Asan Medical Center Institutional Review Board |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Lymphocele Ovarian Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Uterine Cervical Diseases Cysts Lymphatic Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013