The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Leakage rate
研究概览
简要总结
Colorectal resection due to benign and malignant diseases is a commonly performed procedure. The continuity of the gastrointestinal tract is re-established by creating an anastomosis. Although such procedures are often performed, anastomotic techniques and postoperative outcomes usually vary. Failure of the anastomosis might be a life-threatening condition after colorectal resection. A relatively high incidence of anastomotic leaks (up to 30%) has been reported worldwide. Anastomotic failure could happen due to several reasons, that are divided into surgeon-related factors and patient-related factors. So far, there has been no data about the incidence of anastomotic leak in the Western Balkans and the Mediterranean countries.The aim of EAST-WEST Colorectal Study 2022 is to investigate differences in patients undergoing colorectal resections, including pre-operative patient preparation, history of prior surgeries and anastomotic techniques. In addition, this study aims to collect data about post-operative complication rate within 30 days post-surgery across Balkan countries (Slovenia, Serbia, Macedonia, Croatia, BIH and Monte Negro), Greece, Romania and Malta, hence the study outcomes could be applicable to the Mediterranean region, in which patients share a common set of characteristics. This would enable variabilities in practice to be identified and differences regarding postoperative outcomes to be highlighted.
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
- — 至 90 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18-90 years old undergoing colorectal resection with anastomosis due to benign and malignant diseases
- •Any of the procedures listed below performed as an emergency or elective surgery, and by any approach; open, laparoscopic or robotic:
- •Right hemicolectomy and extended right hemicolectomy
- •Ileocecal resection
- •Transverse colon resection
- •Segmental colonic resection - i.e. splenic resection
- •Left hemicolectomy
- •Sigmoid resection
- •Rectal resection
- •Pan-proctocolectomy
排除标准
- •Closure of ileostomy or colostomy
- •Creation of multiple anastomoses
- •Small bowel resection
- •Pelvic exenteration
- •Cytoreductive surgery
结局指标
主要结局
Leakage rate
时间窗: 30 days
次要结局
- 30-day postoperative morbidity(30 days)
- Clavien-Dindo complication classification(30 days)
- Re-admission rate within the first 30 days post-surgery.(30 days)
- Length of stay(30 days)
- 30-day postoperative mortality(30 days)
研究者
George Theodoropoulos
Professor of Surgery
National and Kapodistrian University of Athens
