Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies
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
- 否
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
Antonio Simone Laganà
Principal Investigator
University of Palermo
