NCT02733770

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

March 26, 2016

Last Update Submit

March 24, 2025

Conditions

Portal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Measurement of Portal flow

    physiological parameter

    three month

Secondary Outcomes (1)

  • Determine the relation between the operation and thrombosis

    three month

Study Arms (2)

Sleeve gastrectomy

ACTIVE COMPARATOR

US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomyProcedure: Laparoscopic mini gastric bypass

Mini Gastric Bypass

ACTIVE COMPARATOR

US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass

Procedure: Laparoscopic sleeve gastrectomyProcedure: Laparoscopic mini gastric bypass

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Doppler ultrasound.

Mini Gastric BypassSleeve gastrectomy
Laparoscopic mini gastric bypassPROCEDURE

Doppler ultrasound.

Mini Gastric BypassSleeve gastrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients accepted for bariatric surgery for the bariatric surgery committee.
  • Primary procedure
  • No hypercoagulability status know

You may not qualify if:

  • Hypercoagulability status
  • patients after any abdominal surgery of the forgut

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta MC

Tel Aviv, Israel

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Dpartment of Surgery

Study Record Dates

First Submitted

March 26, 2016

First Posted

April 12, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2021

Study Completion

December 1, 2021

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)