Lymphadenectomy in Right Hemicolectomy: Italian Multicenter Study (CoDIG-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 788
- 试验地点
- 61
- 主要终点
- the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed
研究概览
简要总结
The objective of the study is the analysis of lymphadenectomy in the course of right hemicolectomy, in relation to the radicality of the surgical resection that is performed. In particular, the investigators wants to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity.
The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study
详细描述
All the high-volume specialist centres that perform this type of intervention in Italy will be invited, with a minimum number of 25 interventions per year. At the end of the study 788 patients was enrolled.
The data of the patients involved will be collected independently and anonymously by the individual centers involved, using a common alpha numeric code decided by the coordinating center.
The parameters examined will be:
- Personal data of the patient
- Stage of neoplasm due to surgery
- Type of surgery and duration
- Post-operative course
- Presence of post-surgical complications and eventual hospital readmission due to these complications
- Study of the operating piece and lymphadenectomy performed:
Tumor free margin Terminal ilium length The different vascular ligatures and levels at which they are performed Integrity of the mesocolon Number of positive nodes per total removed
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients and/or legal guardians, where applicable, have been fully informed and have voluntarily provided informed written consent or patients unable to read and/or write who have fully understood the information verbally provided by the investigator and who have provided a verbal consent testified in writing by a third person.
- •Patients aged > 18, men and women, operated by laparoscopic right hemiolectomy or video assisted, under election regime at the U.O. General and Thoracic Surgery with diagnosis of colic adenocarcinoma at any stage.
- •Patients who have already undergone chemotherapy and radiotherapy for other reasons.
排除标准
- •Under age.
- •Patients undergoing emergency surgery.
- •Women who are pregnant.
- •Patients with right-handed laparotomy
结局指标
主要结局
the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed
时间窗: 6 months
In particular, the invastigators want to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity. In the study various items about lymphadenectomy will be invastigated: tumor free margin \> 5cm, lenght of teminal ileum \> 10cm, different level at which colic vessel are closed (proximal or distal ligation) and consequentially the different lymph nodes stations collected, mesocolic sail integrity based on Benz score, number of lymph node harvest and number of lymph nodes positive for metastatic involvement, type of surgical procedure (video-assisted, laparoscopic, robotic).
次要结局
- Vascular anatomical variability(6 months)
研究者
Gabriele Anania
Prof.
University Hospital of Ferrara