NL-OMON54710已完成不适用
Initial non-operative treatment strategy versus appendectomy treatment strategy for simple appendicitis in children aged 7-17 years old. APAC study - Initial non-operative treatment for acute simple appendicitis in children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Eligible for inclusion are all children from 7 to 17 years old, inclusive, with
- •a radiologically confirmed simple appendicitis. Definition of simple
- •appendicitis is based upon predefined clinical, biochemical and radiological
- •(ultrasound) criteria.
- •Clinical & biochemical criteria:
- •- Unwell but not generally ill
- •- Localized tenderness in the right iliac fossa region
- •- Normal/hyperactive bowel sounds
- •- No guarding or palpable mass
- •- Biochemical signs of infection (Elevated White Blood Cell count (WBC) and/or
- •C-reactive protein (CRP)).
- •As recommended by the national guideline, all children with a clinical and/or
- •biochemical suspicion should undergo ultrasound studies. Ultrasound criteria to
- •confirm the diagnosis of acute simple appendicitis are:
- •- An incompressible, painful appendix with an outer diameter > 6 mm
- •- Secondary signs of inflammation such as surrounding fat infiltration, limited
- •clear free fluid surrounding the appendix, hyperemia within the appendiceal
- •- No fecolith, no signs of perforation, no signs of intra-abdominal abscess or
- •In case the ultrasound is inconclusive, additional imaging studies may be
- •obtained. CT-scan is not recommended in the young children (due to its risk of
- •radiation induced malignancy). MRI is recommended in those places with
- •sufficient experience in the interpretation of the results. Only those in whom
- •imaging studies confirm the diagnosis of simple appendicitis can be included.
- •In case there is no certain diagnosis and a *watchful waiting* strategy is
- •chosen, the patient cannot be included.
排除标准
- •Generalized peritonitis, complex appendicitis or sepsis (based upon
- •predefined criteria and scoring system).
- •Scoring system: As scoring system was developed determining the risk of
- •complex appendicitis based upon five pre-operative variable. Points have been
- •awarded to each variable. In case the total score is less than 4 points, the
- •patient is likely to have a simple appendicitis. In case the score is 4 or more
- •points, the chance of having complex appendicitis is significant and those
- •children will be excluded from this study. Variables:
- •Diffuse abdominal guarding (3 points)
- •CRP level more than 38 mg/L (2 points)
- •Signs on ultrasound indicative of complex appendicitis (2 points)
- •More than one day abdominal pain (2 points)
- •Temperature: more than 37.5 degree Celsius (1 point)
- •Fecolith (ultrasound)
- •Serious co-morbidity
- •Recurrent appendicitis
- •Suspicion of an underlying malignancy or inflammatory bowel disease
- •Documented type 1 allergy to the antibiotics used.
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