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临床试验/NCT05318170
NCT05318170已完成不适用

Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies

University of Palermo1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Complications

研究概览

简要总结

Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable.

To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • At least one bulky lymph node with size ≥ 25 mm
  • Age > 18 years
  • Body mass index (BMI) < 40 kg/m²
  • Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation

排除标准

  • Disease-free interval < 6 months and/or
  • Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria

结局指标

主要结局

Complications

时间窗: During the surgery and within 30 days after the surgery

Any complication occurred

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Simone Laganà

Principal Investigator

University of Palermo

研究点 (1)

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