Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Feasibility (pertaining to adherence to follow-up assessment)
研究概览
简要总结
More than 10% of Canadians have gallstones, and approximately 10% of these individuals will develop gallbladder inflammation related to gallstones, which is referred to as acute cholecystitis (AC). Patients with AC who do not have their gallbladder surgically removed have a 30% risk of serious complications that can lead to death. Surgery is the only definitive treatment for AC, however, there is controversy regarding the ideal timing of surgery. The two main approaches are early surgery (typically within 7 days of diagnosis) or delayed surgery (7 days to 6 weeks after diagnosis). Although preliminary evidence suggests that early surgery is associated with shorter hospital length of stay, lower risk for complications, and lower costs, practice varies widely regarding the timing of surgery. The limitations of the existing studies include small sample sizes, varied definitions of early versus delayed surgery, and an imbalance of risk between study groups. The proposed pilot study aims to inform the design of a large clinical trial that will compare the outcomes of patients with AC who receive accelerated surgery (i.e., as soon as possible with a goal of surgery within 6 hours of diagnosis) with those who receive standard care.
详细描述
The prevalence of gallstones is 10% and approximately 10% of patients develop acute cholecystitis (AC). AC prevalence increases with age and complications are as high as 30% in patients who do not undergo surgery, the only definitive treatment. There is controversy regarding ideal surgical timing. Previously, delayed surgery was thought to decrease bile duct injuries resulting from active inflammation. However, the state of persistent inflammation, hypercoagulability, and stress can cause medical complications such as myocardial injury. Chronic inflammation can lead to fibrosis, adhesions and higher chance of bile duct injuries during delayed surgery. There is also concern for recurrent AC episodes, recurrent pain, biliary pancreatitis, cholangitis or sepsis.
Recent studies suggest that early surgery may be associated with better outcomes, but practice remains variable, ranging anywhere from early surgery (<7 days) to delayed surgery (>7 days). Among >24,000 Ontarians with AC admitted to 106 hospitals, timing of cholecystectomy varied widely across sites. Only 58% of patients underwent surgery within 7 days. High volume hospitals were more likely to perform early surgery.17
Among 14,200 Ontarians with AC, a propensity score analysis demonstrated that early surgery was associated with less bile duct injury (relative risk (RR)=0.53, 95% confidence interval (CI) 0.31-0.90) and shorter length of hospital stay (LOS) (mean 1.9 days, 95% CI 1.7-2.1). Early surgery was less costly and more effective than delayed cholecystectomy.
Trials of surgical timing in patients with AC are limited. The largest randomized controlled trial (RCT) compared early and delayed surgery for AC only included 618 patients.9 Cholecystectomy was performed a median of 1 day after randomization in the early group compared to a median of 25 days in the delayed group. Duration of surgery and conversion rate to open surgery were similar in both groups. Early surgery was associated with less morbidity (11.8% vs. 34.4%, p<0.001), shorter LOS (5.4 vs. 10.0 days, p<0.001), and lower cost (€2919 vs. €4262, p<0.001).
Multiple meta-analyses have suggested that early surgery for AC is associated with fewer wound infections (RR 0.57; 95% CI 0.35-0.93) and have suggested a trend to fewer complications (RR 0.66; 95% CI 0.42-1.03). Limitations of these meta-analyses include studies with small sample sizes, few events, wide confidence intervals, and variation in the definition of early surgery. Finally, there is a lack of strong evidence to make definitive conclusions regarding impact of early surgery in AC, which has led to substantial variation in clinical practice.
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
- Single (Outcomes Assessor)
盲法说明
allocation group will not be displayed. All personal identifying information will be removed and a computer generated participant ID will be used instead.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥45 years; or age ≥18 years and <45 years with at least one of the following co-morbidities: diabetes or chronic respiratory, cardiovascular, or renal disease;
- •Diagnosis of acute cholecystitis defined by the presence of at least 2 of the following:
- •Abdominal pain in upper right quadrant,
- •Murphy's sign,
- •Leukocytosis >10 × 103/μl, or
- •Oral temperature <36.5°C or >38°C;
- •Cholelithiasis (stones/sludge);
- •Ultrasound signs of cholecystitis;
- •Acute cholecystitis that requires surgery and is diagnosed during working hours;
- •Expected to require at least an overnight hospital admission after surgery; and
- •Provide written informed consent to participate in FAST.
- •Exclusion Criteria
- •Patients requiring emergent surgery or emergent interventions for another reason;
- •Patients whose therapeutic anticoagulation is not reversible;
- •Patients with a history of heparin-induced thrombocytopenia and current use of warfarin with an INR ≥1.5;
- •Pregnant patients;
- •Previous participation in the trial.
排除标准
- 未提供
结局指标
主要结局
Feasibility (pertaining to adherence to follow-up assessment)
时间窗: 90 days post-randomization
Proportion of patients with missed assessments and incomplete data variables
Feasibility (pertaining to patient recruitment)
时间窗: 1 year
Proportion of patients who are randomized into the trial.
Feasibility (pertaining to patients who are randomized to Accelerated Care)
时间窗: Within 6 hours after diagnosis of acute cholecystitis
Proportion of patients who have surgery initiated within 6 hours of the diagnosis of acute cholecystitis among those randomly assigned to accelerated care.
次要结局
- Subtotal cholecystectomy rate(1 year)
- Proportion of patients who experience e a composite of Clinical Outcomes(90 days after randomization)
- Proportion of patients who experience acute kidney injury(90 days after randomization)
- Proportion of postoperative ileus(2 weeks)
- Hospital Length of Stay(2 weeks)
- Length of surgical procedure(1 week)
- Proportion of patients who experience intra-operative cholangiogram(1 day)
- Proportion of patients who are admitted to ICU within 90 days of randomization(90 days after randomization)
- Number of hospital readmissions within 90 days of randomization(90 days after randomization)
- Proportion of patients who experience peripheral arterial thrombosis within 90 days of randomization(90 days after randomization)
研究者
P.J. Devereaux
PHRI Perioperative and Digital Health Research Director
Population Health Research Institute