- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02733770
Chances in Portal System Flow After Two Bariatric Procedures
Comparison in Portal Flow After Sleeve Gastrectomy and Mini Gastric Bypass
Obesity if a health endemic problem over the entire world. Bariatric surgery is the best chance for those patients with morbid obesity to loss weight and to maintain the loosed weight.
Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the portal vein system. This phenomena may be attributed to changes in the portal flow due to devascularization of the great curvature of the stomach.
The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were the vascularization is not changed by the surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tel Aviv, Israel
- Recruiting
- Assuta MC
-
Contact:
- Sergio Susmallian, M.D.
- Email: sergio9@bezeqint.net
-
Principal Investigator:
- Sergio Susmallian, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients accepted for bariatric surgery for the bariatric surgery committee.
- Primary procedure
- No hypercoagulability status know
Exclusion Criteria:
- Hypercoagulability status
- patients after any abdominal surgery of the forgut
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Sleeve gastrectomy
US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy
|
Doppler ultrasound.
Doppler ultrasound.
|
ACTIVE_COMPARATOR: Mini Gastric Bypass
US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass
|
Doppler ultrasound.
Doppler ultrasound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Portal flow
Time Frame: three month
|
physiological parameter
|
three month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the relation between the operation and thrombosis
Time Frame: three month
|
physiological parameter and number of thrombosis found.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
three month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMC0416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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