A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)
试验速览
- 阶段
- 不适用
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- Rates of ambulatory appendectomy patients that have ambulatory surgery
研究概览
简要总结
This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy
详细描述
Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide.
Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions.
At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization.
There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA.
There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 14 years of age and who provide informed consent to participate in the study.
- •Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision)
- •Negative appendicectomy.
排除标准
- •Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis)
- •Need to place intraoperative drainage.
- •Patients with American Society of Anesthesiologists (ASA) >IV.
- •Immunosuppressed patients.
- •Pregnant.
- •Possibility of inflammatory bowel disease.
- •No family support.
- •No informed consent signature.
- •Impossibility to comply with the established follow-up
结局指标
主要结局
Rates of ambulatory appendectomy patients that have ambulatory surgery
时间窗: 20 months
Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
Rates of readmission of appendectomy patients that had ambulatory surgery
时间窗: 20 months
Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery
次要结局
- Prevalence of ambulatory appendectomy patients(20 months)
- Media of time until the total incorporation to the activities of the daily life after appendectomy(20 months)
- Rates of satisfaction(20 months)
- Costs of the outpatient regimen versus the hospitalization of patients(20 months)