Clinical trial NCT04683666: Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery
Official title: Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery. A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical Procedure
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
Collaborators: name: Dr. Negrin University Hospital
First posted: 2020-12-24
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included were morbidly obese patients or patients with severe obesity associated with obesity-related comorbidities

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ASA IV

Primary outcomes:
measure: Medical complications
timeFrame: 90 days after surgery
measure: Septic complications
timeFrame: 90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Dr Negrin
name: Asuncion Acosta
role: STUDY_DIRECTOR
References: