Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study

Pulmonary Embolism Clinical Trial

Official title:

Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02128178
• Other study ID #: Enoxaparin
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 22, 2014
• Last updated: April 7, 2015
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2015
• Source: Mansoura University
• Contact: mohamed e abd ellatif, phd
• Email: surg_latif[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.

Description:

Two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• BMI >40 OR >35 with comorbidities

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Embolism
• Morbid Obesity
• Obesity, Morbid
• Pulmonary Embolism

Intervention

Drug:
• Enoxaparin 40 mg 2 hours before arm
Enoxaparin 40 mg 2 hours before surgery
• Enoxaparin 40 mg 12 hours before arm
Enoxaparin 40 mg 12 hours before surgery

Locations

Country	Name	City	State
Egypt	Manoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thrombosis and/or pulmonary embolism (PE)	To assess the venous thrombosis by compression ultrasonography and PE in suspected patients	Postoperative 4 weeks	Yes
Secondary	Bleeding from the surgery site , drain if any, GIT bleeding,	Bleeding from drain, GIT, or wounds are assessed clinically	postoperative 4 weeks	Yes
Secondary	hospital stay	hospital stay in days	4 WEEKS	Yes