Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Asan Medical Center
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

ClinicalTrials.gov processed this record on August 20, 2014