跳至主要内容
临床试验/NCT06344078
NCT06344078招募中不适用

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).

Societa Italiana di Chirurgia ColoRettale1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年1月1日最近更新:
适应症

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

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

发起方
Societa Italiana di Chirurgia ColoRettale
申办方类型
Network
责任方
Principal Investigator
主要研究者

Donato F Altomare

DR FERRARA FRANCESCO

Societa Italiana di Chirurgia ColoRettale

研究点 (1)

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