Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Composite score of 30-day mortality and postoperative complications
研究概览
简要总结
In the ProPEL study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. The protocol addresses issues of both frailty and ceiling-of -care decisions.
详细描述
In the "ProPEL" study, investigators will test the effect of a care bundle designed for patients aged ≥75 years undergoing emergency laparotomy/laparoscopy. An interdisciplinary team of anesthetists, intensivists, surgeons, and geriatricians developed the care bundle, and the essential elements are frailty scoring, surveillance and optimization of patients, surgical treatment within predefined criteria, and postoperative delirium monitoring.
Preoperatively, patients with abdominal pathology requiring emergency surgery will be evaluated for frailty by the surgical team, using standardized frailty scores. Palliative care could be an alternative to surgery in very frail patients. The decision to not perform surgery is a clinical decision made with the patient and/or relatives in a shared decision-making process. Frailty scoring can assist in this procedure.
The effect of the care-bundle will be compared to a historical cohort, using 30-day mortality as the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above 75 years with clinical suspicion of abdominal condition requiring surgery
排除标准
- •Former inclusion in "ProPEL"
- •Surgery for incarcerated hernia without laparotomy
- •Appendectomy without laparotomy
- •Palliative surgery for already known inoperable gastrointestinal tumor
- •Palliation without surgical treatment
- •Vascular surgery
结局指标
主要结局
Composite score of 30-day mortality and postoperative complications
时间窗: Up to 30 days after the performance of emergency abdominal surgery
Composite score will be calculated using the Comprehensive Complication Index ranging from 0 points (uneventful postoperative recovery) to 100 points (postoperative death). One investigator will review the patient's medical record postoperatively to investigate if any medical complication has occurred. Complications are defined according to the EPCO definitions and graded according to the Clavien-Dindo classification system.
次要结局
- Postoperative complications(up to 90 days after date of emergency surgery)
- Frequency of post-operative delirium(up to 30 days after emergency surgery)
- Length of stay in hospital after EAS(up to 90 days after emergency surgery)
- Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after surgery(Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal surgery.)
- Level of care at discharge from hospital and one year after EAS(1 year after EAS.)
- 1-year mortality(From time of EAS performed and up to 1 year)
- Days at home in first postoperative year(From date of discharge from hospital after EAS and up to one year postoperatively)
- Readmissions after EAS(From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge.)
- Patient Reported Outcome Measures (PROM)one year after EAS(One year after procedure performed (EAS).)
- 5-year survival(From inclusion in study and up to five years after EAS.)
- 30-day mortality in all patients with indication to undergo surgery(Time (days) up to 30 days after treatment decision (palliation or surgery) is made)