Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

Sponsor
Assuta Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03556995
Collaborator
(none)
9,044
1
61
148.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: bariatric surgery patients

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 Design

Study Type:
Observational
Actual Enrollment :
9044 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Score Scale to Assess Risk of Bleeding in Bariatric Surgery
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 31, 2016
Actual Study Completion Date :
Jan 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Bariatric surgery patients

All patients above 18 that underwent bariatric surgery

Other: bariatric surgery patients

Outcome Measures

Primary Outcome Measures

  1. operative or postoperative bleeding complication [30 days postoperative]

    patients underwent any type of bariatric surgery in our medical network

Secondary Outcome Measures

  1. treatment of the complication [30 days postoperative]

    Treated conservatively, re operation, endoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria:all patients that underwent bariatric surgery -

Exclusion Criteria: Under 18 years old

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assuta MC Tel Aviv Israel

Sponsors and Collaborators

  • Assuta Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sergio Gabriel Susmallian, head of the department of general surgery, Assuta Medical Center
ClinicalTrials.gov Identifier:
NCT03556995
Other Study ID Numbers:
  • 01-18
First Posted:
Jun 14, 2018
Last Update Posted:
Jun 18, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2018