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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02128178
Enrollment
700
Registered
2014-05-01
Start date
2013-11-30
Completion date
2016-05-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Pulmonary Embolism

Keywords

Morbid obesity, Laparoscopic surgery, Compression ultrasonography, Pulmonary embolism, Bleeding

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.

Interventions

DRUGEnoxaparin 40 mg 2 hours before arm

Enoxaparin 40 mg 2 hours before surgery

DRUGEnoxaparin 40 mg 12 hours before arm

Enoxaparin 40 mg 12 hours before surgery

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* BMI \>40 OR \>35 with comorbidities

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Venous thrombosis and/or pulmonary embolism (PE)Postoperative 4 weeksTo assess the venous thrombosis by compression ultrasonography and PE in suspected patients

Secondary

MeasureTime frameDescription
Bleeding from the surgery site , drain if any, GIT bleeding,postoperative 4 weeksBleeding from drain, GIT, or wounds are assessed clinically
hospital stay4 WEEKShospital stay in days

Countries

Egypt

Contacts

Primary Contactmohamed e abd ellatif, phd
surg_latif@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026