Clinical trial NCT03556995: Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery
Official title: Score Scale to Assess Risk of Bleeding in Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery Candidate
Complication
Bleeding
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 9044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that underwent any bariatric surgery in Assuta medical network, composed by 4 hospital of High Volume of bariatric surgery.

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.

Eligibility criteria: Inclusion Criteria:all patients that underwent bariatric surgery -

Exclusion Criteria: Under 18 years old

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Primary outcomes:
measure: operative or postoperative bleeding complication
timeFrame: 30 days postoperative
Secondary outcomes:
measure: treatment of the complication
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta MC
Study officials:
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