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

February 14, 2024 updated by: Feng Tian

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

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
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital

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

No

Description

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.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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.
Device: Intermittent Pneumatic Compression Devices
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.
No Intervention: control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative days 3 to 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of surgery
Time Frame: Intraoperative
Duration of the surgery
Intraoperative
Intraoperative body temperature
Time Frame: Intraoperative
Body temperature at the end of the surgery
Intraoperative
Amount of bleeding during surgery
Time Frame: Intraoperative
Amount of bleeding during surgery
Intraoperative

Collaborators and Investigators

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

Sponsor

Feng Tian

Investigators

  • Principal Investigator: Dawei Wang, Doctor, Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZXT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected individual patient data (IPD)，All IPD behind the published results

IPD Sharing Time Frame

Available at any time, without time restrictions

IPD Sharing Access Criteria

Will be made available to learners through the internet

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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