Appendicitis Global Outcomes Study: Identifying areas for whole systems strengthening in emergency care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14,000
- 试验地点
- 37
- 主要终点
- - Time from symptom onset to
研究概览
简要总结
Background
Acute appendicitis is one of the most common surgical emergencies worldwide. Presentation of appendicitis and its management can serve as a benchmark to evaluate the efficiency and effectiveness of emergency health systems. The aim of this prospective cohort study is to identify areas for whole systems strengthening in emergency care using pre-defined key performance measures.
Methodology
This international prospective, multicentre, cohort study will include consecutive patients undergoing appendicectomy for suspected appendicitis. A measurement set comprising key outcome measures has been pre-defined to comprehensively evaluate emergency system performance across the world. Hospital teams of up to 3 collaborators will collect data on consecutive patients of any age undergoing appendicectomy in pre-defined 14-day blocks. Patients will be followed up at 30-days to collect outcome data.
Multiple teams may participate in data collection in the same hospital but in different 14-day blocks. There will be no changes made to routine patient care pathways/management or follow-up in this observational study.
Two hospital level surveys will be included in the study. One is a mandatory site survey for all hospitals participating and the second will be an optional World Health Organisation hospital emergency assessment tool survey. There will be two nested sub-studies on sustainability and waste management, and financing. Consultant Leads in each participating hospital must ensure appropriate study registration approval as per local regulations and this is mandatory for participation.
Discussion
This study will generate granular data on the global variability in appendicectomy management and outcomes, offering insights into access to emergency care, imaging, and minimally invasive surgery. The findings will guide recommendations for both high-income and low- and middle-income countries, informing government policy and improving patient outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •There are no age restrictions, although, if appropriate participating hospitals can choose to only include children or only adults, based on an age cut-off of their choice.
- •All patients undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach should be included. This includes pa5ents who went theatre with suspect appendicitis even if the intraoperative or pathology results found a different diagnosis, so long as an appendicectomy was performed. It also includes patients who went to theatre for reasons other than suspected appendicitis but were found to have appendicitis intraoperatively and underwent appendicectomy. This includes interval appendicectomy and right hemicolectomy if performed for acute appendicitis.
- •Both open and minimally invasive (laparoscopic and robotic) interven5ons are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.
排除标准
- •Appendicectomy for any indication other than suspected or confirmed appendicitis should be excluded. For example, patients having appendicectomy for known appendiceal neoplasm.
- •Patients having appendectomy as part of another surgical procedure should be excluded. For example, patients having removal of appendix as part of a colon cancer procedure are not eligible for inclusion.
- •Natural orifice surgery and endoscopic treatment for suspected appendicitis are excluded. -Patients having surgery for stump appendicitis are excluded.
- •Patients should be entered into study only once. A patient returning to theatre after appendectomy should not be re-entered as a new patients.
结局指标
主要结局
- Time from symptom onset to
时间窗: 30 day follow up
first assessment by the
时间窗: 30 day follow up
surgical team.
时间窗: 30 day follow up
- Proportion of all patients with histology-confirmed appendicitis who had a perforated appendix on histology
时间窗: 30 day follow up
- Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging
时间窗: 30 day follow up
- Proportion of all patients undergoing a laparoscopic approach for appendicectomy
时间窗: 30 day follow up
- Duration from decision to operate to knife to
时间窗: 30 day follow up
skin
时间窗: 30 day follow up
- Proportion of all patients with a histologically normal appendix
时间窗: 30 day follow up
- Post-operative length of stay
时间窗: 30 day follow up
- 30-day overall Clavien-Dindo
时间窗: 30 day follow up
complications
时间窗: 30 day follow up
次要结局
未报告次要终点
研究者
Dr Vishal Michael
Christian Medical College & Hospital Ludhiana