Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants and Rate of Post-operative complications
研究概览
简要总结
Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).
Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.
Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AC within seven days from symptom onset
- •American Society of Anesthesiologist (ASA) physical status ≤ II
- •Age from 21 to 60 years
排除标准
- •Patients with ASA physical status > II
- •Age < 21 years or > 60 years
- •Child classification B or C
- •Choledocholithiasis
- •Acute pancreatitis
- •Severe sepsis
- •Gallbladder perforation
- •Pregnant women
研究组 & 干预措施
Group E: Early LC (n=60)
Early laparoscopic cholecystectomy (within 72h from symptom onset)
干预措施: Early laparoscopic cholecystectomy (Procedure)
Group L: Late LC (n=60)
Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)
干预措施: Late laparoscopic cholecystectomy (Procedure)
结局指标
主要结局
Number of participants and Rate of Post-operative complications
时间窗: 30 days post-operatively
Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate
次要结局
- Number of participants and Rate of Conversion to open cholecystectomy(from the start till the end of surgical procedure)
- Mean and Standard deviation of Length of hospital stay (days) (mean±SD)(from hospital admission till home discharge within 30 days)
- Mean and Standard deviation of Operative duration (hours) (mean±SD)(from surgical incision till suture closure)
- Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)(from surgical incision till suture closure)