The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy

February 18, 2016 updated by: Petros Tzimas, University of Ioannina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population: Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.

Group sample sizes of 42 in group one and 42 in group two achieve 90% power to detect a difference between the group proportions of 0,2500. The proportion in group one (MetS group) is assumed to be 0,0500 under the null hypothesis and 0,3000 under the alternative hypothesis. The proportion in group two (the Non-MetS group) is 0,0500. The test statistic used is the two-sided Likelihood Ratio test. The significance level of the test was targeted at 0,0500. The significance level actually achieved by this design is 0,0909.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with metabolic syndrome
Patients fulfilling criteria to establish the diagnosis of metabolic syndrome
Procedure: Elective abdominal surgery
Patients without metabolic syndrome
Patients not fulfilling criteria of the metabolic syndrome
Procedure: Elective abdominal surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/17-10-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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