Clinical Trials Directory

Trials / Completed

CompletedNCT04683666

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

Status
Completed
Phase
Study type
Observational
Enrollment
177 (actual)
Sponsor
Hospital General Universitario Elche · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBariatric surgeryLaparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), as primary bariatric procedures, were performed. \^Postoperative complications were assessed.

Timeline

Start date
2013-03-15
Primary completion
2018-09-01
Completion
2020-06-15
First posted
2020-12-24
Last updated
2020-12-24

Source: ClinicalTrials.gov record NCT04683666. Inclusion in this directory is not an endorsement.