Optimal Timing for Laparoscopic Cholecystectomy After Percutaneous Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- recurrence tax of cholecystitis
研究概览
简要总结
Percutaneous drainage in acute cholecystitis has been recommended by the recent update of the Tokyo Guidelines for patients with grade II and III disease who are unable to undergo surgical treatment due to their condition or associated comorbidities.
There are no reports providing high-quality scientific evidence on the optimal timing for surgery after percutaneous transhepatic gallbladder drainage, so a consensus has not been reached. The grade III stage generates the most controversy; after percutaneous drainage, delaying the cholecystectomy can lead to new episodes of exacerbation during the waiting period or may limit the procedure to a specific group of patients with this pathology.
The economic impact, including the number of readmissions, increased length of stay, and associated morbidity and mortality, generates controversy regarding the subsequent therapeutic decisions after the medical management of cholecystitis in this special group of patients.
详细描述
A multicentric, blinded, parallel clinical trial is proposed to compare early and late cholecystectomy after percutaneous cholecystostomy (PC).
The primary objective of the present study is to determine the ideal time interval-early versus late-for performing laparoscopic cholecystectomy (LC) in patients who underwent PC. This includes assessing whether recurrence can be reduced. As a secondary aim, to analyze the morbidity and mortality associated with the intervention.
Recruitment and Deadlines
Only surgical departments with an adequate number of patients will be included in the trial to ensure the sample size objective. The selected recruitment period is 18 months.
Study Variables
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •patients over 18 years of age
- •patients candidates for cholecystectomy, in scheduled surgery
- •patients who accept participation and sign informed consent form
排除标准
- •According to the principal investigator criteria, for reasons that make it impossible to correctly follow the treatment.
- •Presence of morbidity associated with the procedure that delays or makes treatment impossible.
结局指标
主要结局
recurrence tax of cholecystitis
时间窗: 6 months after cholecystostomy
% of recurrence of cholecystitis after cholecystostomy in acute cholecystitis
次要结局
- Patient demographics(pre-operative and surgery day)
- Surgery details(pre-operative and surgery day)
- Post-operative patient mortality(30 and 90 days post-surgery)
- Post-operative patient morbidity(30 and 90 days post-surgery)
- Pre-operative patient comorbidities(pre-operative and surgery day)
- Collection of pre-operative patient treatment (includes antibiotic prophylaxis)(pre-operative and surgery day)
研究者
FULTHON FRANK VELA POLANCO
Principal Investigator
Hospital Arnau de Vilanova