Clinical Trial: Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
Brief Summary: To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
Detailed Summary:
Sponsor: Asan Medical Center
Current Primary Outcome: Incidence of lymphocele an lymphatic ascites [ Time Frame: within 1 year after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Asan Medical Center
Dates:
Date Received: September 3, 2012
Date Started: September 2012
Date Completion:
Last Updated: September 3, 2012
Last Verified: September 2012
