KEY TAKEAWAYS
- The trial aimed to test FloSeal’s effectiveness in preventing fluid buildup after pelvic/para-aortic lymph node surgery in gynecological cancer patients.
- The result demonstrated that the FloSeal cuts symptomatic lymphocele risk after pelvic/para-aortic lymph node surgery in gynecological cancer patients, suggesting its effectiveness as a preventive measure.
Researchers aimed to test FloSeal’s effectiveness in preventing fluid buildup after pelvic/para-aortic lymph node surgery in gynecological cancer patients.
About 40 gynecological cancer patients scheduled for surgery were randomly assigned in a 1:1 ratio to either the FloSeal or non-FloSeal groups. The assessment of lymphocele incidence utilized intravenous contrast-enhanced abdominopelvic computed tomography conducted 3–6 months post-surgery. Patients completed a quality of life(QoL) questionnaire 1, 3, and 6 months after surgery. The comparison of symptomatic lymphocele incidence was performed using a chi-square test.
All patients underwent bilateral pelvic lymph node dissection, with a comparable distribution of para-aortic lymph node dissection between the FloSeal and non-FloSeal groups (40% vs. 44.4%, P > 0.999). The mean number of retrieved lymph nodes (total, right pelvic, left pelvic, and para-aortic) was similar between the two groups.
Lymphocele development occurred in one patient (1/20, 5%) in the FloSeal group and three patients (3/18,16.7%) in the non-FloSeal group (P = 0.328). Symptomatic lymphocele incidence was 0% in the FloSeal group and 11% (2/18) in the non-FloSeal group (P = 0.218). The FloSeal group exhibited a shorter mean time to drain removal (4.8 ± 2.0 days vs. 5.3 ± 2.2 days, P= 0.400) and a smaller mean drain volume (1656 ± 1362 mL vs. 2022 ± 2301 mL, P= 0.550).
The result demonstrated that the FloSeal cuts symptomatic lymphocele risk after pelvic/para-aortic lymph node surgery in gynecological cancer patients, suggesting its effectiveness as a preventive measure.
Source: https://www.emma.events/site/programme/?sessiondetail=4534566&trackid=0&a=esgo2023#!
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT01679483
Baek MH, Park JY, Nam JH. FloSeal For Preventing Symptomatic Lymphocele After Pelvic And/Or Para-Aortic Lymphadenectomy In Gynecological Cancers: A Randomized Controlled Trial.
