Raja Isteri Pengiran Anak Saleha Appendicitis Treatment Without Operation - Antibiotic Non-operative Management Strategy Versus Surgery Management Strategy, a Non-Inferiority Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Number of cases of treatment failures in each arm
研究概览
简要总结
The RIPASA score is a Clinical Prediction Rule (CPR) for the diagnosis of acute appendicitis. Since its inception in 2009, the RIPASA score has been validated in various population in healthcare institutions around the world and reported significantly higher sensitivity and specificity when compared to Alvarado score. RIPASA score ranges from 3 to 16.5 with those having a score of less than 7 having a low probability of acute appendicitis and those with a score of 7.5 having a high probability of acute appendicitis.
There has been a trend in the past decade on non-operative management of early-uncomplicated acute appendicitis (EuAA) with antibiotic therapy. This antibiotic non-operative management strategy (AMS) has been reported to work in children, thus avoiding unnecessary emergency operation. In adults presenting with early-uncomplicated acute appendicitis, this management pathway is still uncertain and most randomized controlled trials (RCT) and meta-analysis have not been able to show significant benefit of AMS over surgery management strategy (SMS), partly due to variable treatment efficacy, high recurrence rate within a year and a lack of agreement of whom would constitute a group of EuAA.
The working hypothesis of this study is that RIPASA score as a Clinical Prediction Rule, can determine a group of patients with a diagnosis of EuAA, based on the range of scores (RIPASA score 7.5 - 11.5), who will benefit from an AMS rather than SMS, leading to improve patients' outcomes through a significant reduction in negative appendicectomy rate, shorter length of hospital stay, reduce post-operative complications and changing physician behavior in managing this group of patients to an AMS rather than SMS and ultimately financial cost savings.
The primary specific aim of this study is to compare AMS with SMS in patients with EuAA in a prospective non-inferiority RCT. Secondary specific aims are to determine the range of RIPASA score that can define a group of patients with EuAA, step 3 validation of RIPASA score as a valid CPR and improve patient outcomes in terms of reducing unnecessary negative appendicectomy rate, hospital stay and complications arising from such surgery, and ultimately financial cost savings.
详细描述
Introduction:
Acute appendicitis is one of the most common surgical emergencies, with a lifetime prevalence approximately 1 in 7. The incidence is 1.5-1.9 per 1000 in a male and female population with approximately 1.4 times greater in men than in women.
Despite being a common problem, acute appendicitis remains a difficult diagnosis to establish, particularly in the young, elderly and female of reproductive age. Delay in surgery may risk appendicular perforation and sepsis. Reduced diagnostic accuracy and early surgery risk significantly high negative appendicectomy rate of about 20-40%. Diagnostic accuracy can be further improved by using ultrasonography or computed tomography scan. However, these modalities are costly and may not easily be available when needed.
Clinical prediction rule (CPR) such as Alvarado score, the modified Alvarado score, and the RIPASA score have been developed to improve the diagnostic accuracy of acute appendicitis. Alvarado and Modified Alvarado scores have been reported to have very low sensitivity and specificity when applied to an Asian population with a completely different ethnic origin and diet. Thus RIPASA score was developed specifically for an Asian population and have been reported to have a significantly better sensitivity (98%) and specificity (82%) over the former two scores. Since 2009, the RIPASA score has undergone broad validation in different population settings with a different prevalence of acute appendicitis across the world and reported similarly high sensitivity and specificity.
The standard management of acute appendicitis has remained largely been unchallenged since the late 19th century, largely because of the belief that if left untreated surgically, acute uncomplicated appendicitis will progress to perforation and peritonitis with increased morbidity and mortality. Furthermore current surgical management of acute appendicitis is associated with an unacceptably high negative appendicectomy rate of about 20-40% and significant post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors - Histopathologists will be masked in terms of allocation of the study participants, when reporting histology specimen of appendix removed.
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •More than 12 years of age
- •High probability of early-uncomplicated acute appendicitis with confirmed RIPASA score of 7.5 to 11.5
排除标准
- •12 years of age or less
- •RIPASA score 7 or less, or greater than 12
- •Clinical diagnosis of acute complicated appendicitis with perforation or signs of generalized peritonitis.
研究组 & 干预措施
Amikacin injection
Antibiotic Non-Operative Management Strategy
干预措施: Amikacin Injection (Drug)
Appendicectomy
Surgery Management Strategy
干预措施: Appendicectomy (Procedure)
结局指标
主要结局
Number of cases of treatment failures in each arm
时间窗: 30 days
Treatment failure for AMS is defined as cases where surgery is performed unplanned from time of randomisation up to 30 days follow up with positive histopathological confirmation of acute appendicitis (suppurative or gangrenous or perforated). Treatment failure for SMS group is defined as the unnecessary operation performed where the histopathological report is that of normal appendix, as an indicator of negative appendicectomy rate or cases who did not undergo surgery from time of randomisaton up to 30 days follow-up.
次要结局
- Length of hospital stay(72 to 168 hours)
- Treatment related complications(30 days)
- Treatment cost in US dollar(1 year)
- Recurrence rate(1 year)
- Defining a group with RIPASA score range where AMS is most beneficial(30 days)
- Number of medical sick leave days taken(1 year)
- Number of cases of non-compliance to RIPASA Score guidelines(30 days)
研究者
William Chong Chee Fui
Consultant Surgeon
Raja Isteri Pengiran Anak Saleha Hospital