Chances in Portal System Flow After Two Bariatric Procedures

Not Applicable

Withdrawn

• Conditions: Portal Vein Thrombosis
• Interventions: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Laparoscopic mini gastric bypass

• Registration Number: NCT02733770
• Lead Sponsor: Assuta Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-26
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Study Start: 2017-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve gastrectomy	Laparoscopic sleeve gastrectomy	US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy
Mini Gastric Bypass	Laparoscopic sleeve gastrectomy	US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass
Sleeve gastrectomy	Laparoscopic mini gastric bypass	US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy
Mini Gastric Bypass	Laparoscopic mini gastric bypass	US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass

Primary Outcome Measures

Name	Time	Method
Measurement of Portal flow	three month	physiological parameter

Secondary Outcome Measures

Name	Time	Method
Determine the relation between the operation and thrombosis	three month	physiological parameter and number of thrombosis found. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Assuta MC; 🇮🇱 Tel Aviv, Israel