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

Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery. A Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Complication of Surgical Procedure
• Intervention / Treatment: Procedure: Bariatric surgery

Detailed Description

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

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.

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.

• Study Type: Observational
• Enrollment (Actual): 177

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• ASA IV

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Collaborators: Dr. Negrin University Hospital
• Investigators: Study Director: Asuncion Acosta, Hospital Universitario Dr Negrin

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CEIC13-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No