The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,308
- 试验地点
- 32
- 主要终点
- Overall complications
研究概览
简要总结
Aim of this study is to evaluate the effect of different treatment strategies on overall complications, health related-Quality of Life (hr-QOL) and costs among two subtypes of complex appendicitis in children (<18 years old).
Main research questions: What is the difference in overall complications at three months between:
Subgroup 1 (complex appendicitis without abscess/mass formation): Laparoscopic (LA) and open appendectomy (OA) Subgroup 2: (complex appendicitis with abscess/mass formation): Non-operative treatment (NOT) and direct appendectomy
详细描述
Up till now initiated research projects worldwide mainly focus on simple appendicitis (questioning the necessity of an appendectomy). However, complex appendicitis is associated with significant morbidity (up to 30%), prolonged hospital stay and high costs. Identification of the optimal treatment strategy for children with complex appendicitis is therefore essential. Heterogeneity in the treatment of complex appendicitis still exists in daily practice and reflects the lack of high-quality data and emphasizes the need for well-designed studies. Complex appendicitis can be divided into two subtypes:
- Complex appendicitis without mass/abscess. (subgroup 1) Although (inter)national guidelines agree that appendectomy should be usual care, the optimal approach (open or laparoscopy) is unclear. Laparoscopic appendectomy (LA) is increasingly applied both in adults (80%) and children (60%). Benefits reported for LA in children are, but not limited to, less superficial site infection (SSI), reduced length of hospital stay and significant less postoperative bowel obstruction compared with open appendectomy (OA). Reluctance for usage of LA in this specific subgroup, however, remains due to the potential higher incidence of post-appendectomy abscess formation (PAA) reported. However, the quality of studies on this topic is low and there is considerable inconsistency in results.
- Complex appendicitis with mass/abscess. (subgroup 2) The recommendation made in our national guideline (to perform direct appendectomy in this subgroup) is not in line with the available literature. A recent Cochrane review on this topic could only include two trials and stated that no firm conclusions could be drawn. An older systematic review, including 7 studies in children, concluded that non-operative treatment (NOT) led to fewer complications, specifically SSI and PAA, when compared to direct appendectomy. Still the recommendation from our national guideline is to perform a direct appendectomy based upon good experiences in the pediatric academic centers.
In order to investigate the optimal treatment for children with complex appendicitis we will perform a nationwide, multi-center, comparative, prospective cohort study. For the purpose of this study, treatment strategies will be standardized among the participating hospitals in order to reduce heterogeneity. Prospectively derived, high quality data will be sufficient to answer the research questions regarding the optimal treatment strategy for each subtype of complex appendicitis in the pediatric population. As it is a non-randomized prospective cohort study, propensity score matching technique will be performed in order to estimate the effect of the treatments adjusted for potential confounders.
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for inclusion are all children <18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined criteria:
- •4 or more points on our scoring system developed to predict complex appendicitis. The diagnostic accuracy of this scoring system is 91% (Range: 84-98%). This scoring system consists of five variables (clinical, biochemical and radiological,each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are:
- •Diffuse abdominal guarding (3 points)
- •CRP level more than 38 mg/L (2 points)
- •Signs on ultrasound / imaging indicative for complex appendicitis (2 points)
- •More than one day abdominal pain (2 points)
- •Temperature more than 37.5 degrees Celsius (1 point)
- •High index of suspicion of complex appendicitis by the treating physician. If this is the case, the treating physician will make pre-treatment note upon what clinical, biochemical or radiological variable the high index of suspicion is based.
排除标准
- •Adult patients (=18 years old)
- •Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
结局指标
主要结局
Overall complications
时间窗: 3 months
The proportion of patients experiencing any complication within 3 months after inclusion
次要结局
- Secondary bowel obstruction(3 months)
- Days absent from school, social or sports events(30 days, 3 months)
- Length of hospital stay(3 months)
- Pain medication utilization(30 days, 3 months)
- Quality of Life questionnaire (PedsQL 4.0)(at inclusion/baseline (=day 0), 30 days, 3 months)
- Superficial Site Infection(3 months)
- Quality adjusted life months (QALM's)(3 months)
- Number of days absent from work(30 days, 3 months)
- Level of pain(at inclusion/baseline (=day 0), 3 days, 5 days, 30 days, 3 months)
- Need for appendectomy(3 months)
- Recurrent appendicitis(3 months)
- Early failure of non-operative treatment(3 months)
- Medical costs (iMCQ)(at inclusion/baseline (=day 0), 30 days, 3 months)
- Patient satisfaction questionnaire (PSQ-18)(3 months)
- Quality of Life questionnaire (EQ-5d-Youth/EQ-5d-Proxy)(at inclusion/baseline (=day 0), 30 days, 3 months)
- Non-medical / indirect costs (iPCQ)(at inclusion/baseline (=day 0), 30 days, 3 months)
- Postappendectomy abscess(3 months)
- Total number of extra visits(30 days, 3 months)
- Patient satisfaction questionnaire (Net promotor score)(3 months)
研究者
Ramon Gorter
Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)