NCT07455253

Effectiveness and Cost-effectiveness of VTE Prevention Strategies in Gynecological Surgery

Cost-Effectiveness Analysis of Perioperative Venous Thromboembolism Prevention Strategies in Gynecology Based on Modified Caprini Score: A Retrospective Nested Case-Control Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 234 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Gynecological Surgery

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-05-01
• Completion: 2026-08-15
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: China