Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

Deep Vein Thrombosis Clinical Trial

Official title:

Outcomes of Short-term Perioperative Thromboprophylaxis After Gastrointestinal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709510
• Other study ID #: RetroThrombo
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2021
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of predisposing factors of the patients	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.	3 years follow up