Deep Vein Thrombosis (DVT), Gynecological Surgery, Pulmonary Embolism (PE), Venous Thromboembolism
Conditions
Keywords
Cost-Effectiveness, Prevention, Retrospective Study, Health Economics
Brief summary
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
Detailed description
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
Interventions
None listed
Sponsors
Affiliated Hospital of Nantong University
Nantong No. 1 People's Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female patients aged $\\ge$ 18 years. Underwent inpatient gynecological surgery (benign or malignant indications). Postoperative Caprini risk score $\\ge$ 2. Complete medical and billing records available in the hospital information system.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adjusted Odds Ratio (OR) of Symptomatic VTE | Up to 30 days postoperatively. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed