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

NCT07455253 | Active Not Recruiting

• 1 other identifier: OBGYN-VTE-2025-01
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Cost-Effectiveness; Prevention; Retrospective Study; Health Economics

Outcome Measures

Primary Outcomes (1)

• Adjusted Odds Ratio (OR) of Symptomatic VTE

  Up to 30 days postoperatively.

Secondary Outcomes (3)

• 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

Study Arms (3)

group1

group2

group3

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients undergoing inpatient gynecological surgery at our center between Jan 1, 2021, and Dec 30, 2025

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, China

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: November 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)