Gynecologic Cancer
Conditions
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.
Interventions
DRUGFloseal
application of floseal on intervention arm
Sponsors
Baxter Healthcare Corporation
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Gynecologic cancer patients who need laparotomic bilateral PLND
Exclusion criteria
* Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of pelvic lymphocele | 6 month | Frequency of ipsilateral pelvic lymphocele at post-operative 6th month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative drainage | post-operative 3 days | left and right post-operative drainage |
| lymphedema | post-operative 3 and 6 month | lymphedema symptoms and sign at post-operative 3 and 6 month |
Countries
South Korea
Contacts
Primary ContactYun Hwan Kim, Dr
Outcome results
None listed