Application of IPC During Surgery to Prevent Venous Thrombosis in Gastrointestinal Surgery Patients.

Trial Title: Application of IPC During Surgery to Prevent Venous Thrombosis in Gastrointestinal Surgery Patients.

NCT ID: NCT06260150

Condition: Gastrointestinal Neoplasms
Stomach Neoplasms
Intestinal Neoplasms

Conditions: Official terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Intestinal Neoplasms
Thrombosis
Venous Thrombosis

Conditions: Keywords:
Intraoperative Care
Gastric Cancer
Stomach Neoplasms
Intermittent Pneumatic Compression Devices

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Intermittent Pneumatic Compression Devices
Description: During use, the pressure is gradually reduced from large to small, and pressure is applied in steps, starting from the calf and moving up to the thigh. Every 30 minutes, the patient's skin color of the lower extremities is observed for any abnormalities, and the blood supply status of the distal ends of both lower limbs (palpation of the dorsalis pedis artery pulse) is noted. If any special conditions occur, the procedure must be immediately stopped.
Arm group label: Experimental group

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. Methods of DVT Prevention Methods for preventing DVT include basic prevention, mechanical prevention, and pharmacological prevention, with intermittent pneumatic compression (IPC) being one of the main mechanical methods for DVT prevention. IPC devices are recommended for DVT prevention in domestic and international studies. Existing evidence suggests that intraoperative IPC use, when compared to other nursing measures, reduces the risk of venous thrombosis. IPC is the preferred choice for mechanical prevention. What is IPC? IPC involves cyclic inflation and deflation of inflatable cuffs by a host device to intermittently apply pressure to wrapped limbs. This promotes passive contraction of the muscles within the pressurized limbs, facilitating venous blood flow in the lower limbs, improving slow blood flow conditions, and reducing the risk of clot formation. Current IPC-related research primarily focuses on postoperative patients, with limited research on intraoperative use. Study Objective The study aims to evaluate the effectiveness of intraoperative use of intermittent pneumatic compression devices in preventing deep vein thrombosis in gastrointestinal cancer surgery patients. The significance of this research lies in providing reference evidence for the potential efficacy of intraoperative IPC application in preventing lower limb deep vein thrombosis in gastrointestinal cancer patients.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Voluntarily agree to participate in this study. 2. Age≥18 years old and≤99 years old. 3. Meet the diagnostic criteria for gastrointestinal tumors and undergo laparoscopic gastrointestinal surgery. Exclusion Criteria: 1. Have lower limb venous thrombosis or other lower limb vascular diseases. 2. Congestive heart failure, pulmonary edema, lower limb edema. 3. Severe deformity in the legs. 4. Blood disorders or coagulation abnormalities. 5. Local abnormalities in the lower limbs (such as dermatitis, gangrene, recent skin graft surgery, etc.) 6. Allergy to device/material used.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shandong Provincial Hospital

Address:
City: Jinan
Zip: 250021
Country: China

Start date: April 1, 2023

Completion date: April 2024

Lead sponsor:
Agency: Feng Tian
Agency class: Other

Source: Shandong Provincial Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06260150