Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: A Prospective Study Adjusting for Confounding by Indication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Conversion to Open Surgery
研究概览
简要总结
The goal of this clinical trial is to learn if performing gallbladder surgery early is as safe and effective as delaying it for people with acute cholecystitis (a sudden gallbladder infection). The main questions it aims to answer are:
- Do participants who have early surgery have a similar rate of complications compared to those who have delayed surgery?
- How does the timing of surgery affect the length of the hospital stay?
Researchers will compare two groups:
- An early surgery group
- A delayed surgery group
Participants in the early surgery group had their gallbladder removed within 72 hours of when their symptoms started. Participants in the delayed surgery group were first treated with medications and had their surgery 6-8 weeks later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Yemeni nationals aged 18-70 years
- •A clinical diagnosis of acute cholecystitis confirmed by clinical presentation, laboratory findings, and imaging studies
- •Symptom duration of less than 72 hours at presentation
- •Fitness for general anesthesia (American Society of Anesthesiologists [ASA] physical status classification I-III)
- •Provision of written informed consent
排除标准
- •Evidence of choledocholithiasis or acute cholangitis
- •Severe comorbidities precluding surgery (ASA class IV-V)
- •Coagulopathy (INR >1.5 or platelet count <100,000/μL)
- •Pregnancy
- •Previous major upper abdominal surgery
- •Patient refusal to participate
研究组 & 干预措施
Early Laparoscopic Cholecystectomy (ELC)
Participants underwent laparoscopic cholecystectomy within 72 hours of symptom onset during the index hospital admission.
干预措施: Laparoscopic Cholecystectomy (Procedure)
Delayed Laparoscopic Cholecystectomy (DLC)
Participants received initial non-operative management with antibiotics and analgesics, followed by elective laparoscopic cholecystectomy 6-8 weeks later.
干预措施: Laparoscopic Cholecystectomy (Procedure)
结局指标
主要结局
Conversion to Open Surgery
时间窗: Intraoperative
Rate of conversion from laparoscopic to open cholecystectomy during the procedure.
Overall Postoperative Complications
时间窗: Within 30 days post-surgery
Incidence of any postoperative complication within 30 days
Operative Time
时间窗: Intraoperative
Duration of surgery, measured in minutes from skin incision to skin closure.
次要结局
- Postoperative Length of Hospital Stay(Up to 30 days post-surgery)
- Duration of Postoperative Pain(Up to 30 days post-surgery)
- Time to Return to Normal Daily Activities(Up to 30 days post-surgery)
- 30-Day Readmission Rate(30 days)
研究者
Haitham Mohammed Jowah
Lecturer
Sana'a University