Surgical Italian Guide for the Management of Complicated Acute Diverticulitis in Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- adhesion to guidelines
研究概览
简要总结
This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 yo or older
- •CT scan and WSES classification
- •surgical intervention within 48 hours for acute diverticulitis
排除标准
- •underaged
- •conservative treatment for acute diverticulitis
- •other treatment
- •diagnosis of colorectal cancer at histology
结局指标
主要结局
adhesion to guidelines
时间窗: 1 year follow-up
assess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.
次要结局
- stoma reversal(1 year follow-up)
研究者
Donato F Altomare
DR FERRARA FRANCESCO
Societa Italiana di Chirurgia ColoRettale
