Back to resultsLaparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Primary Purpose
Morbid Obesity, Pulmonary Embolism
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Enoxaparin 40 mg 2 hours before arm
Enoxaparin 40 mg 12 hours before arm
Sponsored by
About this trial
This is an interventional prevention trial for Morbid Obesity focused on measuring Morbid obesity, Laparoscopic surgery, Compression ultrasonography, Pulmonary embolism, Bleeding
Eligibility Criteria
Inclusion Criteria:
- BMI >40 OR >35 with comorbidities
Exclusion Criteria:
- No
Sites / Locations
- Manoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ENOXAPARIN 2 HOURS BEFORE
Enoxaparin 40 mg 12 hours before
Arm Description
Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter
Outcomes
Primary Outcome Measures
Venous thrombosis and/or pulmonary embolism (PE)
To assess the venous thrombosis by compression ultrasonography and PE in suspected patients
Secondary Outcome Measures
Bleeding from the surgery site , drain if any, GIT bleeding,
Bleeding from drain, GIT, or wounds are assessed clinically
hospital stay
hospital stay in days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02128178
Brief Title
Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Official Title
Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Pulmonary Embolism
Keywords
Morbid obesity, Laparoscopic surgery, Compression ultrasonography, Pulmonary embolism, Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ENOXAPARIN 2 HOURS BEFORE
Arm Type
Active Comparator
Arm Description
Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter
Arm Title
Enoxaparin 40 mg 12 hours before
Arm Type
Active Comparator
Arm Description
Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 40 mg 2 hours before arm
Other Intervention Name(s)
First group
Intervention Description
Enoxaparin 40 mg 2 hours before surgery
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 40 mg 12 hours before arm
Other Intervention Name(s)
second group
Intervention Description
Enoxaparin 40 mg 12 hours before surgery
Primary Outcome Measure Information:
Title
Venous thrombosis and/or pulmonary embolism (PE)
Description
To assess the venous thrombosis by compression ultrasonography and PE in suspected patients
Time Frame
Postoperative 4 weeks
Secondary Outcome Measure Information:
Title
Bleeding from the surgery site , drain if any, GIT bleeding,
Description
Bleeding from drain, GIT, or wounds are assessed clinically
Time Frame
postoperative 4 weeks
Title
hospital stay
Description
hospital stay in days
Time Frame
4 WEEKS
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI >40 OR >35 with comorbidities
Exclusion Criteria:
No
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed e abd ellatif, phd
Email
surg_latif@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed e abd ellatif, phd
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manoura University
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed e abd ellatif, phd
Email
surg_latif@hotmail.com
First Name & Middle Initial & Last Name & Degree
mohamed e abd ellatif, phd
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
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