Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis
• Interventions: Diagnostic Test: Duplex Ultrasound

• Registration Number: NCT04709510
• Lead Sponsor: Istanbul Medeniyet University

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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-08-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AllPatients	Duplex Ultrasound	There is only one cohort in this study. They all received the same follow up and ultrasound protocol.

Primary Outcome Measures

Name	Time	Method
The incidence of thromboembolic events by radiological assessment	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 Outcome Measures

Name	Time	Method
Rate of predisposing factors of the patients	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.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Kadikoy, Turkey