Podda Mauro, Serventi Fernando, Mortola Lorenzo, Marini Stefano, Sirigu Danilo, Piga Michela, Pisano Marcello, Coppola Massimiliano, Agresta Ferdinando, Virdis Francesco, Di Saverio Salomone, Cillara Nicola
General, Minimally Invasive and Robotic Surgery Unit, San Francesco Hospital, Via Mannironi 1, 08100, Nuoro, Italy.
General Surgery Unit, Civil Hospital, Alghero, Italy.
Int J Colorectal Dis. 2017 Nov;32(11):1649-1660. doi: 10.1007/s00384-017-2878-5. Epub 2017 Aug 15.
Acute appendicitis (AA) is among the most common causes of lower abdominal pain and admissions to the emergency department. Over the past 20 years, there has been a renewed interest in the conservative management of uncomplicated AA, and several studies demonstrated that an antibiotic-first strategy is a viable treatment option for uncomplicated AA. The aim of this prospective non-randomized controlled, multicenter trial is to compare antibiotic therapy and emergency appendectomy as treatment for patients with uncomplicated AA confirmed by US and/or CT or MRI scan.
All adult patients in the age range 18 to 65 years with suspected AA, consecutively admitted to the Surgical Department of the 13 participating Italian Hospitals, will be invited to take part in the study. A multicenter prospective collected registry developed by surgeons, radiologists, and pathologists with expertise in the diagnosis and treatment of uncomplicated acute appendicitis represents the best research method to assess the long-term role of antibiotics in the management of the disease. Comparison will be made between surgical and antibiotic-first approaches to uncomplicated AA through the analysis of the primary outcome measure of complication-free treatment success rate based on 1-year follow-up. Quality of life, length of hospital stay, pain evaluation, and time to return to normal activity will be evaluated as secondary outcome measures.
Clinicaltrials.gov ID: NCT03080103.
急性阑尾炎（AA）是下腹部疼痛和急诊入院的最常见原因之一。在过去20年中，人们对非复杂性AA的保守治疗重新产生了兴趣，多项研究表明，抗生素优先策略是治疗非复杂性AA的一种可行选择。这项前瞻性非随机对照多中心试验的目的是比较抗生素治疗和急诊阑尾切除术作为经超声和/或CT或MRI扫描确诊的非复杂性AA患者的治疗方法。
所有年龄在18至65岁之间、疑似患有AA且连续入住13家参与研究的意大利医院外科的成年患者，将被邀请参加该研究。由在非复杂性急性阑尾炎诊断和治疗方面具有专业知识的外科医生、放射科医生和病理学家建立的多中心前瞻性收集登记册，是评估抗生素在该疾病管理中的长期作用的最佳研究方法。通过分析基于1年随访的无并发症治疗成功率这一主要结局指标，对非复杂性AA的手术治疗和抗生素优先治疗方法进行比较。生活质量、住院时间、疼痛评估和恢复正常活动的时间将作为次要结局指标进行评估。
Clinicaltrials.gov标识符：NCT03080103。
