Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 主要终点
- re-hospitalization rate for any cause
研究概览
简要总结
To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy
详细描述
This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value < 0.05 was considered significant, and NNT< 10 was considered clinically relevant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 with a diagnosis of Si-NEN;
- •resection of the primary tumor with or without concomitant cholecystectomy;
- •absence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
排除标准
- •presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
结局指标
主要结局
re-hospitalization rate for any cause
时间窗: through study completion, an average of 7 years
the re-hospitalization rate for any cause after primary tumor surgery
次要结局
- mean number of re-hospitalization any cause(through study completion, an average of 7 years)
- re-hospitalization rate for biliary stone disease(through study completion, an average of 7 years)
- mean number of re-hospitalization biliary stone disease(through study completion, an average of 7 years)
- total costs(through study completion, an average of 7 years)
- COmplication rate(through study completion, an average of 7 years)
研究者
Carlo Ingaldi, MD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna