FloSeal for preventing symptomatic lymphocele after pelvic and/or para-aortic lymphadenectomy in gynecological cancers: a randomized controlled trial

IF 0.5 4区 医学 Q4 OBSTETRICS & GYNECOLOGY European journal of gynaecological oncology Pub Date : 2023-01-01 DOI:10.22514/ejgo.2023.080
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Abstract

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.
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FloSeal用于预防妇科癌症盆腔和/或主动脉旁淋巴结切除术后出现症状性淋巴囊肿:一项随机对照试验
评价FloSeal在预防妇科癌症患者盆腔和/或腹主动脉旁淋巴结切除术后出现症状性淋巴囊肿中的作用。2014年10月至2015年4月,将40例计划手术治疗的妇科肿瘤患者按1:1的比例随机分为FloSeal组和非FloSeal组。术后3-6个月,通过静脉造影增强腹部骨盆计算机断层扫描评估淋巴囊肿的发生率。患者于术后1、3、6个月分别填写生活质量问卷。用卡方检验比较症状性淋巴囊肿的发生率。所有患者均行双侧盆腔淋巴结清扫术,每组8例(40%vs。44.4%, p >0.999)行主动脉旁淋巴结清扫术。两组间平均总淋巴结、右盆腔淋巴结、左盆腔淋巴结和主动脉旁淋巴结清扫数相似。FloSeal组1例(1/ 20,5%)和非FloSeal组3例(3/ 18,16.7%)出现淋巴细胞瘤(p = 0.328)。FloSeal组和非FloSeal组的症状性淋巴囊肿发生率分别为0%和11% (2/18)(p = 0.218)。FloSeal组平均排尿间隔时间(4.8±2.0天比5.3±2.2天,p = 0.400)更短,平均排尿量(1656±1362 mL比2022±2301 mL, p = 0.550)更小。妇科癌症患者盆腔和/或腹主动脉旁淋巴结切除术后使用FloSeal可能对预防症状性淋巴囊肿有效。临床试验注册:NCT01679483。
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来源期刊
自引率
25.00%
发文量
58
审稿时长
1 months
期刊介绍: EJGO is dedicated to publishing editorial articles in the Distinguished Expert Series and original research papers, case reports, letters to the Editor, book reviews, and newsletters. The Journal was founded in 1980 the second gynaecologic oncology hyperspecialization Journal in the world. Its aim is the diffusion of scientific, clinical and practical progress, and knowledge in female neoplastic diseases in an interdisciplinary approach among gynaecologists, oncologists, radiotherapists, surgeons, chemotherapists, pathologists, epidemiologists, and so on.
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