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

NCT ID: NCT02128178

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Morbid Obesity Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ENOXAPARIN 2 HOURS BEFORE

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

Group Type ACTIVE_COMPARATOR

Enoxaparin 40 mg 2 hours before arm

Intervention Type DRUG

Enoxaparin 40 mg 2 hours before surgery

Enoxaparin 40 mg 12 hours before arm

Intervention Type DRUG

Enoxaparin 40 mg 12 hours before surgery

Enoxaparin 40 mg 12 hours before

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

Group Type ACTIVE_COMPARATOR

Enoxaparin 40 mg 2 hours before arm

Intervention Type DRUG

Enoxaparin 40 mg 2 hours before surgery

Enoxaparin 40 mg 12 hours before arm

Intervention Type DRUG

Enoxaparin 40 mg 12 hours before surgery

Interventions

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Enoxaparin 40 mg 2 hours before arm

Enoxaparin 40 mg 2 hours before surgery

Intervention Type DRUG

Enoxaparin 40 mg 12 hours before arm

Enoxaparin 40 mg 12 hours before surgery

Intervention Type DRUG

Other Intervention Names

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First group second group

Eligibility Criteria

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Inclusion Criteria

* BMI \>40 OR \>35 with comorbidities

Exclusion Criteria

* No
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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MOHAMED ABDELLATIF

phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohamed e abd ellatif, phd

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Manoura University

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed e abd ellatif, phd

Role: CONTACT

Facility Contacts

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mohamed e abd ellatif, phd

Role: primary

References

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Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.

Reference Type DERIVED
PMID: 36413425 (View on PubMed)

Other Identifiers

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Enoxaparin

Identifier Type: -

Identifier Source: org_study_id

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