Back to resultsChances in Portal System Flow After Two Bariatric Procedures
Primary Purpose
Portal Vein Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Laparoscopic sleeve gastrectomy
Laparoscopic mini gastric bypass
Sponsored by
About this trial
This is an interventional diagnostic trial for Portal Vein Thrombosis
Eligibility Criteria
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
Sites / Locations
- Assuta MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sleeve gastrectomy
Mini Gastric Bypass
Arm Description
US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy
US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass
Outcomes
Primary Outcome Measures
Measurement of Portal flow
physiological parameter
Secondary Outcome Measures
Determine the relation between the operation and thrombosis
physiological parameter and number of thrombosis found. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02733770
Brief Title
Chances in Portal System Flow After Two Bariatric Procedures
Official Title
Comparison in Portal Flow After Sleeve Gastrectomy and Mini Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Thrombosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy
Arm Title
Mini Gastric Bypass
Arm Type
Active Comparator
Arm Description
US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy
Intervention Description
Doppler ultrasound.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic mini gastric bypass
Intervention Description
Doppler ultrasound.
Primary Outcome Measure Information:
Title
Measurement of Portal flow
Description
physiological parameter
Time Frame
three month
Secondary Outcome Measure Information:
Title
Determine the relation between the operation and thrombosis
Description
physiological parameter and number of thrombosis found. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
three month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assuta MC
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Susmallian, M.D.
Email
sergio9@bezeqint.net
First Name & Middle Initial & Last Name & Degree
Sergio Susmallian, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Chances in Portal System Flow After Two Bariatric Procedures
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