Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

NCT04709510 | Completed

• 1 other identifier: RetroThrombo
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosis; short-term thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• The incidence of thromboembolic events by radiological assessment

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

  3 years follow up

Secondary Outcomes (1)

• Rate of predisposing factors of the patients

  3 years follow up

Study Arms (1)

AllPatients

OTHER

There is only one cohort in this study. They all received the same follow up and ultrasound protocol.

Diagnostic Test: Duplex Ultrasound

Interventions

Duplex Ultrasound DIAGNOSTIC_TEST

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

AllPatients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Orhan Alimoglu, Prof

  Istanbul Medeniyet University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Resident (Research Assistant) at General Surgery

Model Details: Retrospective Cohort

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: August 31, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)