Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-02 @ 5:01 AM
Study NCT ID:
NCT03556995
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
2018-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery
Sponsor:
Assuta Medical Center
Organization:
Study Overview
Official Title:
Score Scale to Assess Risk of Bleeding in Bariatric Surgery
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As bleeding is a major risk in bariatric surgeries, we aimed our study to find any predictors to such bleeding within the surgery or 30 days after surgery. The study is a retrospective study collecting patients data, surgeons data, and hospitals data in order to find if any of the factors influencing patients, surgeons or hospitals, has to do with bleeding in these surgeries and if it does impact bleeding in what way. The goal is finding a predictor that it's neutralizing may prevent bleeding in bariatric surgeries.
Detailed Description:
Were collected retrospectively the data of all patients (age 18 and older) that underwent bariatric surgery in Assuta Hospitals (Assuta is a nationwide privet hospitals network), during the years 2013-2016.
Patients underwent one of three procedures:
* laparoscopic sleeve gastrectomy (LSG),
* laparoscopic gastrectomy by-pass (LGBP)
* laparoscopic adjustable gastric band (LAGB) Demographic data of patients was collected (age, gender. BMI, habits, smoking, alcohol consumption etc.), as well as medical history, background diseases, family medical history, previous surgeries and procedures, chronic treatments, use of medications etc., We have also collected surgeons and hospital data - in which hospital was the surgery done? Surgery technique, surgeon's experience, capacity of surgeon - how many bariatric surgeries are done by the surgeon per months? Statistical analyses was done using chi square and Fisher's exact test for analyzing specific single variables. When analyzing the possible connection between BMI and bleeding, BMI values were split into three categories 30\<BMI\<35, 35\<BMI\<40 and BMI\>40. The use of single variable analyses enabled us to focus on a relatively small number of variables in the multivariable analyses. Variables that were statistically significant (p\<0.05) were used as independent variables in logistic regression tests.
Patients underwent one of three procedures:
* laparoscopic sleeve gastrectomy (LSG),
* laparoscopic gastrectomy by-pass (LGBP)
* laparoscopic adjustable gastric band (LAGB) Demographic data of patients was collected (age, gender. BMI, habits, smoking, alcohol consumption etc.), as well as medical history, background diseases, family medical history, previous surgeries and procedures, chronic treatments, use of medications etc., We have also collected surgeons and hospital data - in which hospital was the surgery done? Surgery technique, surgeon's experience, capacity of surgeon - how many bariatric surgeries are done by the surgeon per months? Statistical analyses was done using chi square and Fisher's exact test for analyzing specific single variables. When analyzing the possible connection between BMI and bleeding, BMI values were split into three categories 30\<BMI\<35, 35\<BMI\<40 and BMI\>40. The use of single variable analyses enabled us to focus on a relatively small number of variables in the multivariable analyses. Variables that were statistically significant (p\<0.05) were used as independent variables in logistic regression tests.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: