PDF(Pubmed)
Abstract：
BACKGROUND: Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control after axillary lymphadenectomy without drains and identify the risk factors related to symptomatic seroma.
METHODS: This is a prospective, multicenter, international, and randomized clinical trial. Patients undergoing conservative surgery and axillary lymphadenectomy for breast cancer will be randomized to control group (lymphadenectomy without sealant) or interventional group (lymphadenectomy with sealant Glubran 2®). In any of the study groups, drains are placed. Patients who received neoadjuvant treatment are included. Measurements of the study outcomes will take place at baseline; at 7, 14, and 30 days post-surgery; and at 6-12 months. The primary outcome is symptomatic seroma. Secondary outcomes are seroma volume, morbidity, quality of life, and lymphedema.
CONCLUSIONS: Several studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery.
BACKGROUND: ClinicalTrials.gov, NCT05280353. Registration date 02 August 2022.
METHODS: This is a prospective, multicenter, international, and randomized clinical trial. Patients undergoing conservative surgery and axillary lymphadenectomy for breast cancer will be randomized to control group (lymphadenectomy without sealant) or interventional group (lymphadenectomy with sealant Glubran 2®). In any of the study groups, drains are placed. Patients who received neoadjuvant treatment are included. Measurements of the study outcomes will take place at baseline; at 7, 14, and 30 days post-surgery; and at 6-12 months. The primary outcome is symptomatic seroma. Secondary outcomes are seroma volume, morbidity, quality of life, and lymphedema.
CONCLUSIONS: Several studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery.
BACKGROUND: ClinicalTrials.gov, NCT05280353. Registration date 02 August 2022.
摘要：
背景：乳腺癌手术后的血清瘤是一个常见的实体；因此，文献中描述了不同的产品，目的是减少它。研究最多的是密封剂产品，用吸气排水沟测试。症状性血清肿占无引流腋窝淋巴结清扫术后的19％。这项研究的目的是分析密封剂在无引流的腋窝淋巴结清扫术后血清肿控制中的作用，并确定与症状性血清肿相关的危险因素。
方法：这是一个前瞻性的，多中心，国际,和随机临床试验。接受保守手术和腋窝淋巴结清扫术治疗乳腺癌的患者将被随机分为对照组（无密封剂的淋巴结清扫术）或介入组（有密封剂的淋巴结清扫术Glrubran2®）。在任何研究小组中，排水沟被放置。包括接受新辅助治疗的患者。研究结果的测量将在基线;在手术后7、14和30天;以及在6-12个月进行。主要结果是有症状的血清肿。次要结果是血清肿体积，发病率，生活质量,还有淋巴水肿.
结论：一些研究比较了密封剂产品在腋窝淋巴结清扫术中的使用，但通常与引流管一起使用。我们希望证明接受腋窝淋巴结清扫术的患者可以从无引流的腋窝密封剂中受益，并减少腋窝不适，同时保持良好的生活质量。评估腋窝体积之间的关系，症状,相关危险因素对乳腺癌手术患者血清肿的控制有很大帮助。
背景：ClinicalTrials.gov，NCT05280353。注册日期2022年8月02日。
方法：这是一个前瞻性的，多中心，国际,和随机临床试验。接受保守手术和腋窝淋巴结清扫术治疗乳腺癌的患者将被随机分为对照组（无密封剂的淋巴结清扫术）或介入组（有密封剂的淋巴结清扫术Glrubran2®）。在任何研究小组中，排水沟被放置。包括接受新辅助治疗的患者。研究结果的测量将在基线;在手术后7、14和30天;以及在6-12个月进行。主要结果是有症状的血清肿。次要结果是血清肿体积，发病率，生活质量,还有淋巴水肿.
结论：一些研究比较了密封剂产品在腋窝淋巴结清扫术中的使用，但通常与引流管一起使用。我们希望证明接受腋窝淋巴结清扫术的患者可以从无引流的腋窝密封剂中受益，并减少腋窝不适，同时保持良好的生活质量。评估腋窝体积之间的关系，症状,相关危险因素对乳腺癌手术患者血清肿的控制有很大帮助。
背景：ClinicalTrials.gov，NCT05280353。注册日期2022年8月02日。
