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

March 3, 2026 updated by: Yuquan Zhang, Affiliated Hospital of Nantong University

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

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

Study Overview

Status

Active, not recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nantong, China
        • Affiliated Hospital of Nantong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
group1
group2
group3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjusted Odds Ratio (OR) of Symptomatic VTE
Time Frame: Up to 30 days postoperatively.
Up to 30 days postoperatively.

Secondary Outcome Measures

Outcome Measure
Time Frame
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame: 1 year
1 year
Incidence of Postoperative Bleeding Complications
Time Frame: Up to 30 days postoperatively
Up to 30 days postoperatively
Association of Uterus/Myoma Weight with VTE Risk
Time Frame: Up to 30 days postoperatively
Up to 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGYN-VTE-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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