Cardiovascular Risk Factors of Medical and Septic Complic... | NCT04683666

Studies
Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery

NCT04683666

Sponsor

Hospital General Universitario Elche

Status

Completed

Last Update Posted

Dec 24, 2020Actual

Enrollment

177Actual

Phase

Not provided

Conditions

Complication of Surgical Procedure

Interventions

Bariatric surgery

Countries

Not provided

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

Dec 2020

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

Mar 15, 2013Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Jun 15, 2020Actual

First Submitted Date

Dec 21, 2020

First Submission Date that Met QC Criteria

Dec 21, 2020

First Posted Date

Dec 24, 2020Actual

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

Dec 21, 2020

Last Update Posted Date

Dec 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Ruiz-Tovar, MD, PhD, Clinical Professor, Hospital General Universitario ElchePrincipal Investigator

Lead Sponsor

Hospital General Universitario ElcheOTHER

Collaborators

Name	Class
Hospital Universitario de Gran Canaria Doctor Negrín	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A prospective, observational study of all morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) was performed. We evaluated preoperative comorbidities and cardiovascular risk factors, and the appearance of postoperative complications up to 90 days after surgery.

Detailed Description

This study aimed to identify potential cardiovascular risk factors for postoperative medical and septic complications after bariatric surgery.

Evaluated cardiovascular risk factors include age, the presence of tobacco habit, preoperative diagnosis of T2D, hypertension, dyslipidemia, cardiopathies (including arrhythmias, ischemic cardiopathy or congestive cardiac failure), strokes, Charlson index and analytical parameters of the lipid (triglycerids, total cholesterol and the subfractions High Density Lipoproteins (HDL-cholesterol) and Low Density Lipoproteins (LDL-cholesterol) and glycemic profile (fasting glucose and glycated hemoglobin). Cardiovascular risk factors, such as the Framingham risk score, were analyzed.

Primary outcomes were the appearance of medical and septic postoperative complications. Medical complications include cardiovascular complications (new onset or impairment of acute heart infarction, arrhythmias, cardiac failure or stroke), respiratory complications (pneumonia or respiratory failure) and acute renal failure. Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.

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

177Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bariatric surgery	Procedure	Laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), as primary bariatric procedures, were performed. ^Postoperative complications were assessed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medical complications	Medical complications include cardiovascular complications (new onset or impairment of acute heart infarction, arrhythmias, cardiac failure or stroke), respiratory complications (pneumonia or respiratory failure) and acute renal failure.	90 days after surgery
Septic complications	Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.	90 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI >40 Kg/m2
BMI >35 Kg/m2 associated with obesity-related comorbidities

Exclusion Criteria:

ASA IV

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

The patients included were morbidly obese patients or patients with severe obesity associated with obesity-related comorbidities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asuncion Acosta	Hospital Universitario Dr Negrin	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

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Browse Branches

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