Clinical Trial: Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
Brief Summary:
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.
Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.
A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.
The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.
The investigators designed prospective randomized controlled study as a pilot study.
The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.
Detailed Summary:
Sponsor: Ewha Womans University Mokdong Hospital
Current Primary Outcome: Frequency of pelvic lymphocele [ Time Frame: 6 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Post-operative drainage [ Time Frame: post-operative 3 days ]left and right post-operative drainage
- lymphedema [ Time Frame: post-operative 3 and 6 month ]lymphedema symptoms and sign at post-operative 3 and 6 month
Original Secondary Outcome: Same as current
Information By: Ewha Womans University Mokdong Hospital
Dates:
Date Received: October 28, 2013
Date Started: December 2013
Date Completion: December 2016
Last Updated: February 10, 2015
Last Verified: February 2015
