Spanish National Registry of Anastomotic Leakage in Rectal Cancer Surgery. Observational, Prospective and Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 主要终点
- Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit
研究概览
简要总结
Primary Endpoint:
The main objective of this National Registry is to identify the incidence and to analyse the risk factors for anastomotic leakage in rectal cancer surgery From the operational point of view, the aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center that could enable the establishment of the best standard of care.
Secondary Endpoints:
To determine the real incidence of anastomotic leakage according to the different locations and techniques: uniform definition of anastomotic leakage.
To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR.
To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR.
To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and mortality.
To create and validate an anastomotic leakage predictive Score.
详细描述
Study Procedures:
This is a Registry of the surgical procedure performed in patients undergoing elective surgery for rectal cancer, resected with curative intent, with anastomosis, with or without protective ileostomy.
Patients will be included pre-operatively, through a website access to the study database. This inclusion could be done until the day before surgery. Participating sites must include all patients undergoing rectal cancer consecutively during the study duration (approximately 1 year).
Data will be collected until day 30 after patient´s discharge. No further follow-up is planned, except for those established by clinical practice.
The study aims to be an extensive and comprehensive registry of all patients meeting inclusion criteria for a period of one year.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with not less than 18 years.
- •Patients who are to undergo surgery for rectal cancer (within 15cm from the anal margin by rigid colonoscopy), elective, resected with local curative intent (R0 and R1) and anastomosis with or without proximal stoma .
- •Patient permit registration information of the surgical procedure, which has been submitted by signing the written informed consent.
排除标准
- •Patients underwent the following procedures:
- •No resected.
- •Local resection= R
- •Resection without anastomosis
- •Patients participating in a clinical trial that would alter this trial.
- •Patients who are lacking basic relevant information to complete the requested data in the registry.
结局指标
主要结局
Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit
时间窗: 1 month
The aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center, that could enable the establishment of the best standard of care.
次要结局
- Influence of different stapling devices in rectal anastomotic leakage rate(1 month)
- Incidence of rectal anastomotic leakage rate between different types of surgeon(1 month)
研究者
Blas Flor Lorente
MD
Hospital Universitario La Fe