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
- 1
- 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
研究组 & 干预措施
Outpatient appendectomy
Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed.
Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded.
1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.
干预措施: Outpatient (OA) (Procedure)
Hospitalization appendectomy
Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed.
Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours.
1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.
干预措施: Hospitalization appendectomy (HA) (Procedure)
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)