Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

Completed

• Conditions: Obesity; Complication; Bleeding; Bariatric Surgery Candidate
• Interventions: Other: bariatric surgery patients

• Registration Number: NCT03556995
• Lead Sponsor: Assuta Medical Center

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2016-03-31
• Study Completion: 2018-01-31
• Status Verified: 2018-06
• Study First Submitted: 2018-06-03
• Study First Submitted QC: 2018-06-03
• Study First Posted: 2018-06-14
• Last Update Submitted: 2018-06-15
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9044

Inclusion Criteria

all patients that underwent bariatric surgery -

Exclusion Criteria

Under 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery patients	bariatric surgery patients	All patients above 18 that underwent bariatric surgery

Primary Outcome Measures

Name	Time	Method
operative or postoperative bleeding complication	30 days postoperative	patients underwent any type of bariatric surgery in our medical network

Secondary Outcome Measures

Name	Time	Method
treatment of the complication	30 days postoperative	Treated conservatively, re operation, endoscopy

Trial Locations

Locations (1)

Assuta MC; 🇮🇱 Tel Aviv, Israel