The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447523
• Other study ID #: 19/17-10-2012
• Status: Completed
• Phase: N/A
• First received: May 5, 2015
• Last updated: February 18, 2016
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Complications
• Metabolic Syndrome
• Metabolic Syndrome X
• Perioperative Outcome

Intervention

Procedure:
• Elective abdominal surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.		2 Weeks	No
Primary	Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.		2 Weeks	No
Primary	Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines		2 Weeks	No
Primary	Surgical site infection (superficial or deep) as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.		2 Weeks	No