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

Phase 1

• Conditions: Morbid Obesity; Pulmonary Embolism
• Interventions: Drug: Enoxaparin 40 mg 2 hours before arm; Drug: Enoxaparin 40 mg 12 hours before arm

• Registration Number: NCT02128178
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• BMI >40 OR >35 with comorbidities

Exclusion Criteria

• No

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENOXAPARIN 2 HOURS BEFORE	Enoxaparin 40 mg 12 hours before arm	Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
ENOXAPARIN 2 HOURS BEFORE	Enoxaparin 40 mg 2 hours before arm	Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
Enoxaparin 40 mg 12 hours before	Enoxaparin 40 mg 12 hours before arm	Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter
Enoxaparin 40 mg 12 hours before	Enoxaparin 40 mg 2 hours before arm	Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter

Primary Outcome Measures

Name	Time	Method
Venous thrombosis and/or pulmonary embolism (PE)	Postoperative 4 weeks	To assess the venous thrombosis by compression ultrasonography and PE in suspected patients

Secondary Outcome Measures

Name	Time	Method
Bleeding from the surgery site , drain if any, GIT bleeding,	postoperative 4 weeks	Bleeding from drain, GIT, or wounds are assessed clinically
hospital stay	4 WEEKS	hospital stay in days

Trial Locations

Locations (1)

Manoura University; 🇪🇬 Mansoura, Egypt