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

NCT06260150 | Active Not Recruiting

• 1 other identifier: ZXT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasms; Stomach Neoplasms; Intestinal Neoplasms

Keywords

Intraoperative Care; Gastric Cancer; Stomach Neoplasms; Intermittent Pneumatic Compression Devices

Outcome Measures

Primary Outcomes (1)

• Incidence rate of DVT

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

  Postoperative days 3 to 5

Secondary Outcomes (3)

• Length of surgery

  Intraoperative

• Intraoperative body temperature

  Intraoperative

• Amount of bleeding during surgery

  Intraoperative

Study Arms (2)

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.

Device: Intermittent Pneumatic Compression Devices

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.

Interventions

Intermittent Pneumatic Compression Devices DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Feng Tian: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Related Publications (7)

• Osaki T, Saito H, Fukumoto Y, Kono Y, Murakami Y, Shishido Y, Kuroda H, Matsunaga T, Sato K, Hirooka Y, Fujiwara Y. Risk and incidence of perioperative deep vein thrombosis in patients undergoing gastric cancer surgery. Surg Today. 2018 May;48(5):525-533. doi: 10.1007/s00595-017-1617-4. Epub 2017 Dec 12.

  PMID: 29234961 BACKGROUND

• Brahmandam A, Abougergi MS, Ochoa Chaar CI. National trends in hospitalizations for venous thromboembolism. J Vasc Surg Venous Lymphat Disord. 2017 Sep;5(5):621-629.e2. doi: 10.1016/j.jvsv.2017.04.006. Epub 2017 May 31.

  PMID: 28818212 BACKGROUND

• Kearon C. Natural history of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I22-30. doi: 10.1161/01.CIR.0000078464.82671.78.

  PMID: 12814982 BACKGROUND

• Mauermann WJ, Shilling AM, Zuo Z. A comparison of neuraxial block versus general anesthesia for elective total hip replacement: a meta-analysis. Anesth Analg. 2006 Oct;103(4):1018-25. doi: 10.1213/01.ane.0000237267.75543.59.

  PMID: 17000823 BACKGROUND

• Schlottmann F, Strassle PD, Patti MG. Comparative Analysis of Perioperative Outcomes and Costs Between Laparoscopic and Open Antireflux Surgery. J Am Coll Surg. 2017 Mar;224(3):327-333. doi: 10.1016/j.jamcollsurg.2016.12.010. Epub 2017 Jan 26.

  PMID: 28132820 BACKGROUND

• Liew NC, Alemany GV, Angchaisuksiri P, Bang SM, Choi G, DE Silva DA, Hong JM, Lee L, Li YJ, Rajamoney GN, Suviraj J, Tan TC, Tse E, Teo LT, Visperas J, Wong RS, Lee LH. Asian venous thromboembolism guidelines: updated recommendations for the prevention of venous thromboembolism. Int Angiol. 2017 Feb;36(1):1-20. doi: 10.23736/S0392-9590.16.03765-2. Epub 2016 Sep 8.

  PMID: 27606807 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Stomach Neoplasms; Intestinal Neoplasms

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Dawei Wang, Doctor

  Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 15, 2024
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available at any time, without time restrictions
• Access Criteria: Will be made available to learners through the internet

Locations

CN (1)