Impact of Implementing a National Surgical Emergency Classification on Quality of Life and Persistent Pain at 3 Months: A Single-Center Prospective Before-and-After Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- SF-36 Physical Component Summary (PCS) score at 3 months
研究概览
简要总结
The aim of this study is to evaluate the impact of implementing a national surgical emergency classification system in the emergency operating room in Nice on patients' quality of life and persistent pain 3 months after surgery.
This work is a local ancillary study of the CLASSE trial conducted by the French Society of Anaesthesia and Intensive Care Medicine (SFAR). The primary hypothesis is that implementing a decision-support tool incorporating recommended time-to-surgery targets will improve patients' health status 3 months after surgery, as reflected by higher SF-36 Physical Component Summary (PCS) scores, a lower incidence of persistent and neuropathic pain, and greater patient satisfaction.
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
- 否
入选标准
- •Patient locally enrolled in CLASSE trial
- •Patient aged >18 years
- •Patient receiving initial care
- •Patient having a diagnosis
- •Patient with valid contact information
- •Patient with no objection to ancillary follow-up
- •Patient able to participate in a telephone interview in French.
排除标准
- •Major cognitive impairment.
- •Persistent inability to understand French
- •Hearing or speech impairment incompatible with a standardized telephone interview
- •Explicit refusal at the time of the call.
研究组 & 干预措施
Post-implementation cohort
Participants are included during the corresponding weeks of March 2027, after local implementation of the national surgical-emergency classification and its recommended time-to-surgery targets. No individual exposure is assigned by the investigators.
干预措施: National surgical-emergency classification-based triage (Other)
Pre-implementation cohort
Participants were included locally in CLASSES at CHU de Nice from March 9 to March 22, 2026, when emergency surgical cases were triaged according to usual local practice. No exposure was assigned by the investigators.
干预措施: Usual-practice emergency-surgery triage (Other)
结局指标
主要结局
SF-36 Physical Component Summary (PCS) score at 3 months
时间窗: 3 months after index surgery (day 90 to day 120)
PCS calculated from SF-36 responses using the validated scoring algorithm prespecified in the analysis plan. Higher scores indicate better physical health-related quality of life.
次要结局
- SF-36 Mental Component Summary (MCS) score at 3 months(3 months after index surgery (day 90 to day 120))
- Persistent postsurgical pain at 3 months(3 months after index surgery (day 90 to day 120))