NCT07521969招募中不适用
Safety, Efficacy, and Cost-effectiveness of Outpatient Surgery for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2025年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.
研究概览
简要总结
PHASE II-III CLINICAL TRIAL TO EVALUATE THE SAFETY, EFFECTIVENESS AND EFFICIENCY OF DISCHARGE TO OUTPATIENT SURGERY IN PATIENTS WITH ACUTE GANGRENOUS APPENDICITIS UNDERGOING EMERGENCY SURGERY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Acute gangrenous appendicitis confirmed during surgery.
- •Patient who meets the criteria to be discharged on an outpatient basis
- •Signature of informed consent.
- •Older than 14 years of age
排除标准
- •- Uncomplicated appendectomy.
- •Intra-operative purulent or faecaloid peritonitis
- •Appendicular abscess or plastron diagnosed by imaging.
- •Paralytic ileus preventing oral tolerance.
- •Need for placement of abdominal drainage.
- •ASA IV and some selected ASA III.
- •Immunosuppression.
- •Patients with active neoplasia.
- •Pregnancy.
- •Doubts in the definitive diagnosis.
- •Suspicion of inflammatory bowel disease.
- •No family support.
- •Failure to sign the informed consent form.
- •Impossibility to comply with the follow-up.
研究组 & 干预措施
Case
Experimental
Out management patient
干预措施: outpatient surgery (Other)
Control
Experimental
hospitalised patient
干预措施: Hospitalization (Other)
结局指标
主要结局
Safety of outpatient management of patient with acute gangrenous appendicitis after laparoscopic appendectomy.
时间窗: 1 month after surgery
Numer of hospital readmission
次要结局
- Number of participants achieving discharge criteria based on the Modified Aldrete Score (range 0-10, higher scores indicate better recovery) after appendectomy(Immediately postoperatively (before discharge))
- Determine the causes of failure of the outpatient regimen in our patients.(30 days since the intervention)
- Association between baseline characteristics and failure of outpatient management within 30 days(30 days since the intervention)
- Time off work(30 days since surgery)
- Efficiency of outpatient management(30 days since surgery)
- Degree of satisfaction(30 days since surgery)
研究者
研究点 (1)
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