The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy

Completed

• Conditions: Metabolic Syndrome; Anesthesia; Perioperative Outcome; Complications
• Interventions: Procedure: Elective abdominal surgery

• Registration Number: NCT02447523
• Lead Sponsor: University of Ioannina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-19
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with metabolic syndrome	Elective abdominal surgery	Patients fulfilling criteria to establish the diagnosis of metabolic syndrome
Patients without metabolic syndrome	Elective abdominal surgery	Patients not fulfilling criteria of the metabolic syndrome

Primary Outcome Measures

Name	Time	Method
Surgical site infection (superficial or deep) as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.	2 Weeks
Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.	2 Weeks
Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.	2 Weeks
Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines	2 Weeks