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NCT Number: NCT04709510

Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

Major abdominal surgery for cancer is major risk factor for thromboembolism. Patients who undergo major abdominal surgery are prone to develop venous thromboembolism, both in the early postoperative period and after hospital discharger. There are strong recommendations in the international guidelines in favor to pharmacological thromboprophylaxis. Thus there is no consensus dor the duration of the prophylaxis. There are authors that suggest extended prophylaxis up to 4 week after surgery. On the other hand, there are prospective randomized trials that inpatient (short-term up to 7-10 days) prophylaxis is adequate.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

About this study

This is a retrospective cohort study with 89 patients who underwent major abdominal surgery for colorectal and gastric cancer. All patients received short term prophylaxis (during hospital stay only) rather than extended prophylaxis (4 weeks). All participants received duplex ultrasound in the study period for the diagnosis of deep vein thrombosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18
  • Major abdominal surgery gor colorectal or gastric cancer
  • Caprini Risk score less than 9
  • No history of anticoagulant treatment
  • Thromboprophylaxis during hospital stay only

Exclusion criteria

  • Younger than 18
  • Caprini Risk score 9 and above
  • History of anticogulants
  • Not reachable by phone etc

Treatment and study plan

Duplex ultrasound

Diagnostic Test

Duplex Ultrasound was performed for every participants for the diagnosis of symptomatic or asymptomatic deep vein thrombosis

Primary outcomes

  1. The incidence of thromboembolic events by radiological assessment

    Time frame: 3 years follow up

    All patients in the cohort received short time prophylaxis for deep vein thrombosis instead of prolonged duration. All patients will be assessed with ultrasound.

Secondary outcomes

  1. Rate of predisposing factors of the patients

    Time frame: 3 years follow up

    The patients with deep vein thrombosis in the cohort will be assessed according to their postoperative period features, histories, chemo treatments etc. with and questionnaire.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

Outcomes of Short-term Perioperative Thromboprophylaxis After Gastrointestinal Cancer Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 14, 2021
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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