Cost-Effectiveness Analysis of Perioperative Venous Thromboembolism Prevention Strategies in Gynecology Based on Modified Caprini Score: A Retrospective Nested Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Adjusted Odds Ratio (OR) of Symptomatic VTE
研究概览
简要总结
Venous thromboembolism (VTE) is a highly preventable but potentially fatal complication following gynecological surgery. The Caprini risk assessment model is widely used, but real-world evidence evaluating the net clinical benefit and cost-effectiveness of different prophylaxis strategies (mechanical vs. pharmacological) in gynecological patients with Caprini score $\ge$ 2 is still lacking. This study aims to evaluate the relative effectiveness of basic, mechanical, and pharmacological VTE prophylaxis strategies using a retrospective 1:3 matched nested case-control design. Furthermore, a decision tree model will be constructed to evaluate the incremental cost-effectiveness ratio (ICER) of these strategies to provide health economic evidence for optimizing VTE management pathways in gynecology
详细描述
This is a two-phase study. Phase I is a retrospective nested case-control study. Patients undergoing gynecological surgery between Jan 2021 and Sep 2025 with a Caprini score $\ge$ 2 will be screened. Case group includes patients who developed objectively confirmed symptomatic VTE postoperatively. Control group will be matched at a 1:3 ratio based on age ($\pm$ 5 years), Body Mass Index (BMI), surgical approach, and benign/malignant nature of the disease. Conditional logistic regression will be used to calculate the adjusted Odds Ratios (ORs) for mechanical and pharmacological prophylaxis compared to basic prevention. In addition, uterus/myoma size and weight will be explored as potential gynecological-specific risk factors.
Phase II involves health economic modeling. A decision tree model will be built utilizing the ORs obtained from Phase I, combined with real-world cost data (prophylaxis costs, VTE treatment costs, bleeding management costs) and baseline incidence rates from literature. The Incremental Cost-Effectiveness Ratio (ICER) will be calculated to determine the most cost-effective VTE prevention strategy at different Caprini risk thresholds
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged $\ge$ 18 years. Underwent inpatient gynecological surgery (benign or malignant indications). Postoperative Caprini risk score $\ge$
- •Complete medical and billing records available in the hospital information system.
排除标准
- •Diagnosis of VTE prior to the current surgery. Currently receiving therapeutic anticoagulation for other medical conditions (e.g., atrial fibrillation, mechanical heart valves).
- •Inferior vena cava filter placement prior to surgery. Incomplete key clinical or financial data.
研究组 & 干预措施
group2
group3
group1
结局指标
主要结局
Adjusted Odds Ratio (OR) of Symptomatic VTE
时间窗: Up to 30 days postoperatively.
次要结局
- Incremental Cost-Effectiveness Ratio (ICER)(1 year)
- Incidence of Postoperative Bleeding Complications(Up to 30 days postoperatively)
- Association of Uterus/Myoma Weight with VTE Risk(Up to 30 days postoperatively)
研究者
Yuquan Zhang
professor
Affiliated Hospital of Nantong University