跳至主要内容
临床试验/NCT06655948
NCT06655948尚未招募不适用

Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events

Fondazione Policlinico Universitario Agostino Gemelli IRCCS5 个研究点 分布在 2 个国家目标入组 700 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
700
试验地点
5
主要终点
Prevalence of intraoperative adverse events

研究概览

简要总结

The goal of this prospective, multicentric, observational, cohort study is to evaluate intraoperative adverse events (iAEs) through video-based assessment (VBA) across minimal invasive procedures performed in general surgery departments. The main questions it aims to answer are:

  • The prevalence, type, and severity of iAEs
  • Correlation between iAE and clinical outcomes
  • Correlation between iAE and surgical performance
  • Qualitative analysis of root cause analysis and mitigation strategies

详细描述

The OPERATE study is a prospective, multicenter observational cohort study focused on evaluating the prevalence and impact of intraoperative adverse events (iAEs) during minimally invasive surgeries. The study aims to systematically collect and analyze surgical videos and clinical outcomes from multiple centers. By using advanced video-based assessment (VBA) tools, such as the Objective Clinical Human Reliability Analysis (OCHRA) and the Severity of Intraoperative Events and Rectification (SEVERE) index, the study will examine how surgical performance correlates with post-operative outcomes.

The study will initially focus on colorectal surgery, with the possibility of expanding to other types of minimally invasive procedures. Videos of the surgeries will be recorded, de-identified, and uploaded to a centralized platform for analysis. The study also seeks to identify root causes of iAEs and develop strategies to prevent them. Data collection will include not only video-based assessments but also patient demographic details, surgical history, and post-operative recovery data.

By understanding the frequency and nature of iAEs, this study aims to improve surgical safety, reduce complications, and ultimately enhance the quality of patient care in a broad range of general surgical procedures. The findings may contribute to developing new training protocols, artificial intelligence instruments to model errors and increase procedural safety, and guidelines to optimize surgical performance and patient outcomes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective minimally-invasive surgery in participating centers
  • Patients with no contraindication to anesthesia and laparoscopic procedures
  • Capable of providing informed consent

排除标准

  • Surgery performed with palliative intent or under unplanned/emergency setting
  • Pregnant or breastfeeding patient
  • Patient under legal custody or guardianship

结局指标

主要结局

Prevalence of intraoperative adverse events

时间窗: Day of the surgical procedure (1 day)

The prevalence of iAEs will be assessed using validated VBA tools including the Objective Clinical Human Reliability Analysis (OCHRA), the European Association for Endoscopic Surgery (EAES) classification, and the Severity of Intraoperative Events and Rectification (SEVERE) index.

次要结局

  • Outcomes correlation(From the day of the surgical procedure up to 5 years of follow up)
  • Severity(Day of the surgical procedure (1 day))
  • Video-Based Assessment(Day of the surgical procedure (1 day))
  • Root causes(Day of the surgical procedure (1 day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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