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

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ClinicalTrials.gov Identifier: NCT02128178
Recruitment Status : Unknown
Verified April 2015 by MOHAMED ABDELLATIF, Mansoura University.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
MOHAMED ABDELLATIF, 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Pulmonary Embolism Drug: Enoxaparin 40 mg 2 hours before arm Drug: Enoxaparin 40 mg 12 hours before arm Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Study Start Date : November 2013
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ENOXAPARIN 2 HOURS BEFORE
Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
Drug: Enoxaparin 40 mg 2 hours before arm
Enoxaparin 40 mg 2 hours before surgery
Other Name: First group

Drug: Enoxaparin 40 mg 12 hours before arm
Enoxaparin 40 mg 12 hours before surgery
Other Name: second group

Active Comparator: Enoxaparin 40 mg 12 hours before
Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter
Drug: Enoxaparin 40 mg 2 hours before arm
Enoxaparin 40 mg 2 hours before surgery
Other Name: First group

Drug: Enoxaparin 40 mg 12 hours before arm
Enoxaparin 40 mg 12 hours before surgery
Other Name: second group




Primary Outcome Measures :
  1. Venous thrombosis and/or pulmonary embolism (PE) [ Time Frame: Postoperative 4 weeks ]
    To assess the venous thrombosis by compression ultrasonography and PE in suspected patients


Secondary Outcome Measures :
  1. Bleeding from the surgery site , drain if any, GIT bleeding, [ Time Frame: postoperative 4 weeks ]
    Bleeding from drain, GIT, or wounds are assessed clinically

  2. hospital stay [ Time Frame: 4 WEEKS ]
    hospital stay in days



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI >40 OR >35 with comorbidities

Exclusion Criteria:

  • No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128178


Contacts
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Contact: mohamed e abd ellatif, phd surg_latif@hotmail.com

Locations
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Egypt
Manoura University Recruiting
Mansoura, Egypt
Contact: mohamed e abd ellatif, phd       surg_latif@hotmail.com   
Principal Investigator: mohamed e abd ellatif, phd         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: mohamed e abd ellatif, phd Mansoura University

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Responsible Party: MOHAMED ABDELLATIF, phd, Mansoura University
ClinicalTrials.gov Identifier: NCT02128178     History of Changes
Other Study ID Numbers: Enoxaparin
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by MOHAMED ABDELLATIF, Mansoura University:
Morbid obesity
Laparoscopic surgery
Compression ultrasonography
Pulmonary embolism
Bleeding

Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases