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

April 7, 2015 updated by: MOHAMED ABDELLATIF, Mansoura University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Manoura University
        • Principal Investigator:
          • mohamed e abd ellatif, phd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI >40 OR >35 with comorbidities

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • First group
Drug: Enoxaparin 40 mg 12 hours before arm
Enoxaparin 40 mg 12 hours before surgery
Other Names:
  • 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 Names:
  • First group
Drug: Enoxaparin 40 mg 12 hours before arm
Enoxaparin 40 mg 12 hours before surgery
Other Names:
  • second group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding from the surgery site , drain if any, GIT bleeding,
Time Frame: postoperative 4 weeks
Bleeding from drain, GIT, or wounds are assessed clinically
postoperative 4 weeks
hospital stay
Time Frame: 4 WEEKS
hospital stay in days
4 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: mohamed e abd ellatif, phd, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Enoxaparin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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