Suggesting Score Scale for Risk of Bleeding in Bariatric... | NCT03556995

Studies
Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

NCT03556995

Sponsor

Assuta Medical Center

Status

Completed

Last Update Posted

May 8, 2026Actual

Enrollment

9,044Actual

Phase

Not provided

Conditions

Obesity
Bariatric Surgery Candidate
Complication
Bleeding

Interventions

bariatric surgery patients

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Mar 31, 2016Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Jun 3, 2018

First Submission Date that Met QC Criteria

Jun 3, 2018

First Posted Date

Jun 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 8, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sergio Gabriel Susmallian, head of the department of general surgery, Assuta Medical CenterPrincipal Investigator

Lead Sponsor

Assuta Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As bleeding is a major risk in bariatric surgeries, The study aimed 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., Were 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,044Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric surgery patients		All patients above 18 that underwent bariatric surgery	Other: bariatric surgery patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bariatric surgery patients	Other		Bariatric surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
operative or postoperative bleeding complication	patients underwent any type of bariatric surgery in our medical network	30 days postoperative

Secondary Outcomes

Measure	Description	Time Frame
treatment of the complication	Treated conservatively, re operation, endoscopy	30 days postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:all patients that underwent bariatric surgery -

Exclusion Criteria: Under 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients that underwent any bariatric surgery in Assuta medical network, composed by 4 hospital of High Volume of bariatric surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assuta MC		Tel Aviv			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23338049	Result	Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.
21893621	Result	Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005.

ID	Term
D009765	Obesity
D006470	Hemorrhage

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases