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OpenTrials
Completed

NCT Number: NCT04683666

Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ASA IV

Treatment and study plan

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.

Primary outcomes

  1. Medical complications

    Time frame: 90 days after surgery

    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.

  2. Septic complications

    Time frame: 90 days after surgery

    Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Collaborators

  • Hospital Universitario de Gran Canaria Doctor Negrín

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Dec 24, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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