PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- success of outpatient appendectomy
研究概览
简要总结
The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.
详细描述
Acute appendicitis is one of the most common surgical emergencies and corresponds to an high number of admissions (about 120.000) in France. It mainly affects young adults and is associated to fewer complications and to a short length of stay. The notion of outpatient refers to a shorter hospital length to stay i.e. less than 12 hours without an overnight hospitalization. This notion came from 3 learned society recommendations' (SFCD, ACHBT, and AFCA) and has been considered as a national priority.
There is no consensus about appendectomy in an outpatient setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Non complicated acute appendicitis which has been diagnosed at physical, paraclinical and morphological examination
- •Adult patient
- •Patient with sufficient understanding
- •Good compliance with medical prescription
- •Hygiene and housing equivalent to a hospitalization
- •Availability of an accompanying able to prevent the surgeon if necessary, to accompany the patient and stay at night next to him
- •Less than one hour from an health care adapted to the surgical structure
- •Quick access to a telephone
- •Patient affiliated with social protection
排除标准
- •complicated appendicitis
- •pregnancy or breastfeeding
- •unstable vital signs or fever
- •objective signs of diffuse peritonitis
- •ward of court or prisoners
- •Discovery of a complicated shape (severe sepsis, abscess, generalized peritonitis)
- •Discovery of an alternative diagnosis
- •Performing an associated gesture (colectomy or typhlectomy, annexectomy...)
结局指标
主要结局
success of outpatient appendectomy
时间窗: postoperative day 30
The primary endpoint corresponds to the proportion of outpatient appendectomy defined as the number of patients whose hospital length of stay is less than 12 hours. This endpoint will be evaluated during the consult 30 day after the surgery
次要结局
- the reoperation rate(postoperative day 30)
- The proportion of deprogramming(postoperative day 30)
- post-surgical pain(the day of the surgery prior to the discharge)
- The hospital readmission rate(postoperative day 30)
- The unexpected consultation rate(postoperative day 30)
- post-surgical quality of life(the day of the surgery prior to the discharge)
- The unplanned overnight admission rate(postoperative day 30)