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NCT Number: NCT07455253

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

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Affiliated Hospital of Nantong University

Nantong, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Adjusted Odds Ratio (OR) of Symptomatic VTE

    Time frame: Up to 30 days postoperatively.

Secondary outcomes

  1. Incremental Cost-Effectiveness Ratio (ICER)

    Time frame: 1 year

  2. Incidence of Postoperative Bleeding Complications

    Time frame: Up to 30 days postoperatively

  3. Association of Uterus/Myoma Weight with VTE Risk

    Time frame: Up to 30 days postoperatively

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Collaborators

  • Nantong No. 1 People's Hospital
  • The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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