Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Comparison between early and late laparoscopic cholecystectomy regarding Operation time
研究概览
简要总结
This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.
详细描述
The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.
This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A & B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.
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
- •Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
- •Initial surgical management planned for immediate laparoscopic cholecystectomy.
- •Patients who are fit for laparoscopy and general anesthesia.
- •Patient who agree to provide short term outcome data and agree to provide contact information.
排除标准
- •Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
- •Patients with other associated abdominal pathology.
- •Patients with any previous abdominal surgery or any significant systemic disease.
- •Septic shock.
- •Pregnancy/ Breast-feeding mothers.
- •Participation in an additional drug or device study and inability to offer informed consent.
结局指标
主要结局
Comparison between early and late laparoscopic cholecystectomy regarding Operation time
时间窗: intra-operative
comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes
Duration of postoperative hospital stay
时间窗: within 2 weeks post-operative
comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital
Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation
时间窗: intra-operative
comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy
comparison between early and late laparoscopic cholecystectomy regarding post operative pain
时间窗: within 1month post operative
comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics
次要结局
- comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding(7 days postoperative)
- presence of any wound complication by examining the wound(within 10 days post-operative)
- comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage(first 72 hours post-operative)
研究者
Mohamed Elmahdy Ali Abdel Rahman Morsy
Resident Doctor
Assiut University