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临床试验/NCT06260150
NCT06260150进行中(未招募)不适用

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

Feng Tian1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Incidence rate of DVT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Experimental group

Experimental

On the basis of routine nursing, the intermittent pneumatic compression device was used, lasting from the start of the operation to the end of the operation.

干预措施: Intermittent Pneumatic Compression Devices (Device)

control group

No Intervention

The control group received routine nursing during the operation, including upper limb intravenous puncture to establish infusion channel, and anesthesiologist performed radial artery puncture and catheterization. The patients were placed in a 30° head-up, legs-down position with their legs apart, and were warmed up by a warm air blanket. The intraoperative warming device was set to infuse at 38℃, and bladder temperature was monitored. Knee-length graded compression stockings (GCS) were used for both legs during the operation.

结局指标

主要结局

Incidence rate of DVT

时间窗: Postoperative days 3 to 5

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

次要结局

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

研究者

发起方
Feng Tian
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Feng Tian

Associate Professor

Shandong Provincial Hospital

研究点 (1)

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