Comparison of incidence of VTE after abdominoplasty surgery between groups receiving pneumatic pump with and without anticoagulant drugs

Comparison of incidence of VTE after abdominoplasty surgery between groups receiving pneumatic pump with and without anticoagulant drugs generally and by Age, Sex, Surgery duration, weight and BMI

A randomized, parallel-group, open-label, phase 3 clinical trial conducted on 128 patients. Randomization was performed using an online random number table.

VTE is one of the most common preventable causes of morbidity and mortality in hospitalized patients, especially in intensive care units. Venous thrombosis typically occurs in the deep veins of the legs and can lead to life-threatening pulmonary embolism. In this context, the study will be conducted at Amir al-Mu'minin Hospital in Tehran, comparing the use or non-use of anticoagulant medications along with a pneumatic compression pump to prevent VTE. The study will be conducted as a field study and clinical trial, and the data will be analyzed using SPSS version 26. No blinding will be applied in this study.

Inclusion Criteria: Elective surgery ASA 1 or 2 Age between 18 and 65 years No use of drugs, alcohol, cigarettes, or psychoactive substances Signed informed consent form for participation in the study Exclusion Criteria: Hemodynamic disorder

Both groups will receive general anesthesia, and the pneumatic compression pump will be started at the beginning of surgery. One group will use only the pump, while the other will also receive 5000 units of heparin at the end of surgery. The incidence of DVT and thromboembolism will be recorded at 6 and 24 hours postoperatively.

Incidence of Venous Thromboembolism (VTE): The diagnosis of VTE includes deep vein thrombosis (DVT) or pulmonary embolism (PE), determined using diagnostic methods (Doppler ultrasound or CT angiography). Type: Binary categorical (presence or absence of VTE)

Randomization Method For randomizing patients in this study, block randomization with a fixed block size will be used. This method ensures that the number of patients in the two groups (pneumatic pump alone and pneumatic pump with anticoagulant drug) is allocated equally, maintaining balance throughout the study. Randomization Process Step 1: Designing the Randomization List A randomization list will be created using software such as Random Allocation Software. The block size will be fixed (blocks of 4 participants). For each block, the possible allocation combinations to the two groups will be determined randomly. Step 2: Generating Allocation Codes Random allocation codes will be generated and stored in a list. Each allocation code corresponds to one of the groups ("A" for the pneumatic pump alone group and "B" for the pneumatic pump with anticoagulant drug group). Step 3: Packaging the Codes The random allocation codes will be placed in sealed and numbered envelopes to prevent prediction of the allocation by the investigator. Implementation of Randomization at the Study Site After confirming the patient's eligibility for the study and obtaining written informed consent, the patient will receive a numbered envelope in the order of their entry into the study. The allocation code inside the envelope will be opened by a person unaware of the study design, and the patient will be assigned to the corresponding group. Blinding In this study, due to the differences in interventions (use of anticoagulant drugs), complete blinding for the execution team is not feasible. However, the primary outcome assessment (the incidence of venous thromboembolism) will be performed by a specialist who is blinded to the group allocation. Documentation and Monitoring All randomization and allocation steps will be documented and kept in a separate protocol notebook. An independent monitor (External Monitor) will review the randomization process and ensure its accurate execution. This standard randomization method ensures balance between the groups and reduces the potential for bias.

A table of de-identified patient characteristics along with the occurrence of venous thromboembolism (VTE). Clinical Study Report

Access period begins 12 months after publication of results.

Researchers employed in academic and scientific institutions

The data will be permitted for use in research at academic and scientific institutions.

Applicants meeting the specified criteria can submit their request for documentation via the following email address. Upon review and approval of the request, the documentation will be sent to them: dr.vahdatmanesh@gmail.com

The request must be approved by the researcher and the project team, and this process will take a maximum of 3 weeks.