Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Frequency of pelvic lymphocele
研究概览
简要总结
To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.
详细描述
Pelvic lymph node dissection is the most accurate staging tool to determine lymph node involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study, conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometrial cancer patients who need laparotomic bilateral PLND
- •Patients suitable for surgery
排除标准
- •Previous pelvic surgery
- •Previous Chemotherapy or Radiotherapy
- •Patients who undergo only lymph node sampling
- •Patients who have not signed Informed Consent
研究组 & 干预措施
Conventional pelvic lymphadenectomy
Conventional pelvic lymphadenectomy
干预措施: Conventional Pelvic lymphadenectomy (Procedure)
Thrombin gel matrix pelvic lymphadenectomy
Thrombin gel matrix applicated after conventional pelvic lymphadenectomy
干预措施: Thrombi-Gel (Drug)
结局指标
主要结局
Frequency of pelvic lymphocele
时间窗: post-operative 2th month
Frequency pelvic lymphocele at post-operative 2th month
次要结局
- Volume of radiographic lymphoceles(post-operative 2th month)
- duration of postoperative drainage catheter(up to post-operative 1 week)
- Postoperative drain amount (ml: milliliters)(with 1 weeks after surgery)
研究者
Şener Gezer
Principal Investigator
Kocaeli University