NCT Number: NCT02447523
The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy
Worldwide, the rising incidence of obesity has led to the identification of an obesity related syndrome, called metabolic. This syndrome is characterized by central obesity, hypertension, insulin resistance and altered lipid levels.
Taking into consideration the rising incidence of obesity, anesthetists will more frequently encounter patients with metabolic syndrome, in their everyday practice. Moreover, the comorbidities that are related to the metabolic syndrome, increase the risk for perioperative complications. Therefore, strategies that will evaluate and modify the risk will be of great importance in the management of these patients, in order to maximize peri-anaesthetic and surgical safety.
The aim of the study is to assess the incidence of metabolic syndrome and the impact of its presence on the outcome of patients undergoing elective laparotomy.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.
Exclusion criteria
- Endstage neoplasia
- Procedures performed within 1 hour of admission
- Emergency cases
Treatment and study plan
Primary outcomes
-
Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
Time frame: 2 Weeks
-
Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
Time frame: 2 Weeks
-
Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Time frame: 2 Weeks
-
Surgical site infection (superficial or deep) as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
Time frame: 2 Weeks
Sponsors and collaborators
Lead sponsor
University of Ioannina
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- May 19, 2015
- Registry last updated
- Feb 19, 2016
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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