Chances in Portal System Flow After Two Bariatric Procedures

March 6, 2020 updated by: Sergio Gabriel Susmallian, Assuta Medical Center

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Assuta MC
        • Contact:
        • Principal Investigator:
          • Sergio Susmallian, M.D.

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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
Procedure: Laparoscopic sleeve gastrectomy
Doppler ultrasound.
Procedure: Laparoscopic mini gastric bypass
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
Procedure: Laparoscopic sleeve gastrectomy
Doppler ultrasound.
Procedure: Laparoscopic mini gastric bypass
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

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

Sponsor

Assuta Medical Center

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 (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

March 26, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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