Metabolic SyndromeNCT02447523
The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy
An observational study of Metabolic Syndrome and Anesthesia, run by University of Ioannina.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Syndrome, Anesthesia, Perioperative Outcome
- What is being tested?
- Elective abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.
Who cannot join
- Endstage neoplasia
- Procedures performed within 1 hour of admission
- Emergency cases
About this study
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.
- Conditions
- Metabolic Syndrome, Anesthesia, Perioperative Outcome, Complications
- Being tested
- Elective abdominal surgery
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective abdominal surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with metabolic syndrome | Patients fulfilling criteria to establish the diagnosis of metabolic syndrome Receives: Procedure: Elective abdominal surgery | |
| Patients without metabolic syndrome | Patients not fulfilling criteria of the metabolic syndrome Receives: Procedure: Elective abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
Measured: 2 Weeks
Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
Measured: 2 Weeks
Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Measured: 2 Weeks
Surgical site infection (superficial or deep) as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petros Tzimas, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447523
- Sponsor's protocol ID
- 19/17-10-2012
- Status last verified
- Feb 2016
- First submitted
- 5 May 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy
- ClinicalTrials.gov ID
- NCT02447523
- Acronym / sponsor ID
- 19/17-10-2012
- Conditions
- Metabolic Syndrome, Anesthesia, Perioperative Outcome, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with metabolic syndrome | – | Procedure: Elective abdominal surgeryPatients fulfilling criteria to establish the diagnosis of metabolic syndrome |
| Patients without metabolic syndrome | – | Procedure: Elective abdominal surgeryPatients not fulfilling criteria of the metabolic syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.
Key exclusion criteria (3 listed)
- Endstage neoplasia
- Procedures performed within 1 hour of admission
- Emergency cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective abdominal surgery | Procedure or surgery | Patients with metabolic syndrome, Patients without metabolic syndrome |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Anesthesia, run by University of Ioannina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines. (time frame: 2 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.