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OpenTrials
Completed

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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Key information

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

Elective abdominal surgery

Procedure

Primary outcomes

  1. Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.

    Time frame: 2 Weeks

  2. Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.

    Time frame: 2 Weeks

  3. Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines

    Time frame: 2 Weeks

  4. 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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