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Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

Primary Purpose

Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Duplex Ultrasound
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, short-term thromboprophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medeniyet University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AllPatients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 8, 2021
Last Updated
January 13, 2021
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT04709510
Brief Title
Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery
Official Title
Outcomes of Short-term Perioperative Thromboprophylaxis After Gastrointestinal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
deep vein thrombosis, short-term thromboprophylaxis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Retrospective Cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AllPatients
Arm Type
Other
Arm Description
There is only one cohort in this study. They all received the same follow up and ultrasound protocol.
Intervention Type
Diagnostic Test
Intervention Name(s)
Duplex Ultrasound
Intervention Description
Duplex Ultrasound was performed for every participants for the diagnosis of symptomatic or asymptomatic deep vein thrombosis
Primary Outcome Measure Information:
Title
The incidence of thromboembolic events by radiological assessment
Description
All patients in the cohort received short time prophylaxis for deep vein thrombosis instead of prolonged duration. All patients will be assessed with ultrasound.
Time Frame
3 years follow up
Secondary Outcome Measure Information:
Title
Rate of predisposing factors of the patients
Description
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.
Time Frame
3 years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orhan Alimoglu, Prof
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
State/Province
Kadikoy
ZIP/Postal Code
34722
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

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