APPLE Study (APPendicitis and Laparoscopic Evaluation) Study; Multicenter Prospective Validation of the Laparoscopic APPendicitis (LAPP) Score
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Negative appendectomy
研究概览
简要总结
SUMMARY
Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis appendicitis. However until recently evidence-based laparoscopic criteria for determining appendicitis were not defined. If there is any doubt about the presence of appendicitis the appendix is usually removed. In a single centre prospective pilot study on 134 patients the investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current study the investigators will validate the LAPP score in order to decrease the negative appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.
Objective: To decrease the negative appendectomy rate by 50%.
Study design: A multicenter prospective validation study
Study population: All patients, ≥18 years, operated with a diagnostic laparoscopy for the clinical suspicion appendicitis. Sample size calculation, performed by a statistician/ epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.
Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843), were retrospectively analysed for negative appendectomies. This cohort will serve as the control group. In this control group no intervention was given, as the LAPP score was not yet defined.
In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic laparoscopy. With the LAPP score the investigators intend to halve the number of negative appendectomies.
Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%. This decrease should not lead to an increase in missed appendicitis (occurring within 30 days), defined as requiring a surgical re-intervention or as an appendicitis or appendicular infiltrate on an ultrasound or CT-scan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of implementation of the LAPP score is minimal. In theory, the use of the LAPP score might lead to an increase risk in missed appendicitis. This might lead to an increase in morbidity.
详细描述
- INTRODUCTION AND RATIONALE
During the last decade, a laparoscopic approach for a suspicion of appendicitis has become more common in surgical practice. In case the appendix looks normal the guideline of the Dutch Society of Surgeons advices not to remove it. [1] The morbidity of a negative appendectomy is approximately 6% and it also leads to additional costs. [2] However, until recently no criteria on how to assess the appendix during a laparoscopy has been published. In a recently performed pilot study the investigators defined the Laparoscopic APPendectomy (LAPP) score. [3] The LAPP score is an easy applicable score that can be used during a diagnostic laparoscopy to evaluate the appendix on the presence or absence of 5 laparoscopic criteria on appendicitis. In our prospective cohort, use of the LAPP score would have led to a positive predictive value of 99% and a negative predictive value of 100%.
The goal of the current study is to validate the LAPP score in a prospective multicenter validation study. Our hypothesis is that the application of the LAPP score leads to a reduction of 50% of negative appendectomies compared with a retrospective cohort in the same centers. The investigators have chosen to compare the negative appendectomy rate of this prospective multicenter validation study with a retrospective control group. The control group consists of 843 patients operated in 5 centers in 2008 and 2009 with a negative appendectomy rate of 9%.
The most ideal design would be a clustered center randomized trial. In such a case half of the hospitals will be asked to use the LAPP score and the other half should assess the appendix the conventional way. The investigators feel that it is not feasible, as they already presented the LAPP score at the national congress for surgeons. In addition, after publication of the results of the LAPP study surgeons might already start to use the LAPP score or at least will evaluate the appendix differently than before. [3] 2. OBJECTIVES
Primary Objective: To reduce the negative appendectomy rate with 50% compared with the retrospective control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients operated for the clinical suspicion of acute appendicitis that will undergo a diagnostic laparoscopy.
- •Age ≥ 18 years.
- •Written informed consent
排除标准
- •Diagnostic laparoscopy and planned appendectomy for an appendectomy a froid.
- •Primarily chosen for an open appendectomy.
- •Not able to give informed consent (for example language barrier or legally incapable).
- •Refused informed consent.
研究组 & 干预措施
LAPP score
Use of the LAPP score during a diagnostic laparoscopy.
干预措施: LAPP score (Procedure)
结局指标
主要结局
Negative appendectomy
时间窗: 3 months postoperatively
Either a histologically proven normal appendix or in case of no appendectomy a 3 months disease free clinical course.
次要结局
- Missed appendicitis(3 months)
研究者
JW Haveman
MD, PhD
University Medical Center Groningen