Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Gallstone related complications
研究概览
简要总结
In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy in our locality of conservative management and delayed cholecystectomy. However, evidence to support early cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients with mild biliary pancreatitis.
详细描述
Inclusion criteria
-
Patient diagnosed with a first attack of mild biliary pancreatitis
-
Age ≥ 18 years
-
American Society of Anesthesiologists (ASA) grade I, II or III
-
a serum C-reactive protein (CRP) concentration less than 100 mg/L,
-
no need for opioid analgesics,
-
normal oral diet tolerance Exclusion criteria
-
chronic pancreatitis 2. alcohol abuse 3. pregnancy The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, we found that 53 patients should be present in each group. Eligible patients will be randomly divided into two equal groups (Group 1: early cholecystectomy, Group 2: delayed cholecystectomy) according to a computer-generated random numbers.
Procedure Early cholecystectomy was done within 48 after admission. Delayed cholecystectomy was done after 30 days after randomization. All cholecystectomies were done by, or under the direct supervision of, a surgeon who had undertaken at least 100 cholecystectomies in the past 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient diagnosed with a first attack of mild biliary pancreatitis
- •Age ≥ 18 years
- •American Society of Anesthesiologists (ASA) grade I, II or III
- •a serum C-reactive protein (CRP) concentration less than 100 mg/L,
- •no need for opioid analgesics,
- •normal oral diet tolerance
排除标准
- •chronic pancreatitis
- •alcohol abuse
研究组 & 干预措施
early cholecystectomy
Early cholecystectomy was done within 48 after admission
干预措施: early cholecystectomy (Procedure)
delayed cholecystectomy
Delayed cholecystectomy was done after 30 days after randomization.
干预措施: delayed cholecystectomy (Procedure)
结局指标
主要结局
Gallstone related complications
时间窗: 6 month of onset of pancreatitis
recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
次要结局
- Conversion to open cholecystectomy(up to 2 hours)
- Operative time(up to 10 hours)
- Cholecystectomy related complications(up to 1 month)
- Gall stones non related complications(up to 6 month)
- Length of hospital stay of index admission(from admission to discharge of patient, up to 10 days)
- Number of readmission(up to 6 month)
- Total length of hospital stay (including readmission)(up to 6 month)
- The number of patient-reported colics irrespective of readmission(up to 6 month)
- Need for intensive care unit admission(up to 6 month)
- Mortality(up to 6 month)
- Difficulty of cholecystectomy(up to 3 hours)
- additional surgical, endoscopic, or radiological intervention(up to 6 month)
研究者
Mohammed Ahmed Omar
Lecturer of GIT surgery and laparoendoscopy
South Valley University