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Clinical Trials/NCT06260150
NCT06260150Active, not recruitingNot Applicable

Interventional Study on the Application of Intermittent Pneumatic Compression Device During Surgery to Prevent Lower Limb Venous Thrombosis in Gastrointestinal Surgery Patients

Feng Tian1 site in 1 country120 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Incidence rate of DVT

Study Overview

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of intraoperative intermittent pneumatic compression (IPC) device usage in preventing lower extremity deep vein thrombosis (DVT) in patients undergoing gastrointestinal surgery.The main question it aims to answer is provide a reference basis for determining the efficacy of IPC application during gastrointestinal surgery for preventing lower extremity DVT in patients.

Participants are patients who require gastrointestinal surgery, specifically for the resection of gastrointestinal tumors. They will be divided into a control group and an experimental group. The experimental group will use an Intermittent Pneumatic Compression (IPC) device during surgery, while the control group will receive standard treatment. The objective is to observe whether the use of IPC during surgery can prevent the formation of Deep Vein Thrombosis (DVT) or lower the Risk of DVT.

Detailed Description

Gastrointestinal Cancer is a highly prevalent malignant tumor, with a high incidence ranking worldwide.

Deep Vein Thrombosis (DVT) Formation Deep Vein Thrombosis (DVT) refers to the pathological phenomenon of abnormal blood clot formation within the deep venous system, leading to partial or complete blockage of the vessel lumen. It results in venous reflux disorders, primarily occurring in the lower limbs. DVT is one of the most common serious complications among surgical patients and is characterized by a high incidence and high mortality rate. Slow blood flow, venous wall damage, and a hypercoagulable state are three recognized major factors contributing to DVT formation.

Prevention of DVT in Gastrointestinal Cancer Patients Pre and Post-Surgery Studies have shown that both preoperative and postoperative DVT incidence rates are relatively high among gastrointestinal cancer patients. Over the years, researchers have primarily focused on preoperative and postoperative DVT prevention, with limited research on intraoperative prevention. Despite significant reductions in DVT incidence, the annual number of cases and deaths remains substantial.

Intraoperative DVT Formation Research has found that lower limb thrombosis mainly occurs within the first 2 hours after surgery, and more than half of the thrombi are believed to originate intraoperatively. Factors contributing to intraoperative DVT risk include prolonged patient immobilization, the use of anesthesia, muscle relaxants, sedatives during surgery, as well as the effects of laparoscopy, pneumoperitoneum, and patient positioning, significantly increasing the risk of DVT formation.

DVT Risk in Gastrointestinal Cancer Surgery Laparoscopic surgery is the primary curative treatment for gastrointestinal cancer. Factors contributing to DVT risk in laparoscopic surgery include pneumoperitoneum-induced compression of the inferior vena cava and iliac veins, increased vascular resistance, elevated diaphragm causing increased thoracic pressure, reduced venous return due to prolonged leg muscle inactivity during extended surgical durations, and positioning of patients with the head elevated and feet lowered, leading to reduced venous return, slow blood flow, and an increased risk of thrombosis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Voluntarily agree to participate in this study.
  • Age≥18 years old and≤99 years old.
  • Meet the diagnostic criteria for gastrointestinal tumors and undergo laparoscopic gastrointestinal surgery.

Exclusion Criteria

  • Have lower limb venous thrombosis or other lower limb vascular diseases.
  • Congestive heart failure, pulmonary edema, lower limb edema.
  • Severe deformity in the legs.
  • Blood disorders or coagulation abnormalities.
  • Local abnormalities in the lower limbs (such as dermatitis, gangrene, recent skin graft surgery, etc.)
  • Allergy to device/material used.

Outcomes

Primary Outcomes

Incidence rate of DVT

Time Frame: Postoperative days 3 to 5

The rate of lower limb DVT occurrence in patients within 3 to 5 days post-surgery before discharge

Secondary Outcomes

  • Length of surgery(Intraoperative)
  • Amount of bleeding during surgery(Intraoperative)
  • Intraoperative body temperature(Intraoperative)

Investigators

Sponsor
Feng Tian
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Feng Tian

Associate Professor

Shandong Provincial Hospital

Study Sites (1)

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