FloSeal for preventing symptomatic lymphocele after pelvic and/or para-aortic lymphadenectomy in gynecological cancers: a randomized controlled trial
1Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, 05505 Seoul, Republic of Korea
2Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, 10408 Goyang-si, Republic of Korea
DOI: 10.22514/ejgo.2023.080 Vol.44,Issue 5,October 2023 pp.67-74
Submitted: 08 April 2023 Accepted: 24 May 2023
Published: 15 October 2023
To evaluate the role of FloSeal for preventing symptomatic lymphocele following pelvic and/or para-aortic lymphadenectomy in patients with gynecological cancers. Between October 2014 and April 2015, 40 patients with gynecological cancers planned for surgical management were randomly placed into FloSeal and non-FloSeal groups in a 1:1 ratio. Lymphocele incidence was evaluated using intravenous contrast-enhanced, abdominopelvic computed tomography 3–6 months after surgery. The quality of life questionnaire was completed by patients at 1, 3 and 6 months after surgery. The incidence of symptomatic lymphocele was compared using a chi-square test. All patients underwent bilateral pelvic lymph node dissection, and eight patients in each group (40%vs. 44.4%, p > 0.999) underwent para-aortic lymph node dissection. The mean number of total, right pelvic, left pelvic and para-aortic lymph nodes retrieved was similar between the groups. One patient (1/20, 5%) in the FloSeal group and three (3/18, 16.7%) in the non-FloSeal group developed lymphoceles (p = 0.328). The incidence of symptomatic lymphocele was 0% and 11% (2/18) in the FloSeal and non-FloSeal groups (p = 0.218), respectively. The mean time interval to drain removal (4.8 ± 2.0 days vs. 5.3 ± 2.2 days, p = 0.400) was shorter and the mean drain volume (1656 ± 1362 mL vs. 2022 ± 2301 mL, p = 0.550) was smaller in FloSeal group. The use of FloSeal after pelvic and/or para-aortic lymphadenectomy in patients with gynecological cancers may be effective for preventing symptomatic lymphocele. Clinical Trial registration: NCT01679483.
Lymphocele; Lymphocyst; Lymphadenectomy; Lymph node dissection; Gynecological cancer; FloSeal
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