跳至主要内容
临床试验/NCT05544487
NCT05544487尚未招募不适用

The Effect of Preoperative Factors and Surgical Technique on Postoperative Outcomes in Patients Undergoing Colorectal Resections at South-eastern Europe.

National and Kapodistrian University of Athens0 个研究点目标入组 300 人开始时间: 2022年10月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Theodoropoulos

Professor of Surgery

National and Kapodistrian University of Athens

相似试验