Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- retrieved lymph nodes
研究概览
简要总结
Background: An exact lymph node staging is essential in the treatment of rectal cancer.
Objective: The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision (taTME).
Design: This is a retrospective, non-randomised study. Settings: This study was conducted at a tertiary hospital by a multidisciplinary team.
Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were analysed. Patients with indigo carmine injection (intervention group) were compared to those without (control group).
Interventions: Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection.
Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary outcome measure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.
排除标准
- •abdominoperineal resection
- •extended colon resection
- •previous surgery of the rectum, the left colon or the mesocolon/-rectum
- •patients rejecting retrospective data analysis
结局指标
主要结局
retrieved lymph nodes
时间窗: 1 - 7 days after surgery
number of lymph nodes retrieved by pathologist from the specimen
次要结局
- N stage(1 - 7 days after surgery)
- survival(5 years)
- positive lymph nodes(1 - 7 days after surgery)
研究者
Walter Brunner
Senior Consultant
Cantonal Hospital of St. Gallen