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

Mansoura University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pulmonary Embolism; Morbid Obesity

Treatments: Drug: Enoxaparin 40 mg 12 hours before arm; Drug: Enoxaparin 40 mg 2 hours before arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02128178

Enoxaparin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI >40 OR >35 with comorbidities

Exclusion criteria

• No

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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700 participants in 2 patient groups

ENOXAPARIN 2 HOURS BEFORE

Active Comparator group

Description:

Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter

Treatment:

Drug: Enoxaparin 40 mg 2 hours before arm

Drug: Enoxaparin 40 mg 12 hours before arm

Enoxaparin 40 mg 12 hours before

Active Comparator group

Description:

Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter

Treatment:

Drug: Enoxaparin 40 mg 2 hours before arm

Drug: Enoxaparin 40 mg 12 hours before arm