Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04683666 |
Other study ID # |
CEIC13-2 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 15, 2013 |
Est. completion date |
June 15, 2020 |
Study information
Verified date |
December 2020 |
Source |
Hospital General Universitario Elche |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.