Risk Factors and Impact of Anesthesia Techniques on Myocardial Infarction Following Transurethral Resection of the Prostate

August 5, 2019 updated by: Chang Gung Memorial Hospital

Risk Factors and Impact of Anesthesia Techniques on Myocardial Infarction Following Transurethral Resection of the Prostate: a Nationwide Database Case Control Study

This study examined the risk factors and the influence of the type of anesthetic used during transurethral resection of the prostate (TURP) on subsequent incidence of myocardial infarction (MI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study utilized a population-based, nationwide dataset to evaluate the risk factors of MI for patients with benign prostate hypertrophy (BPH) who received TURP. Besides, The study also compared the different effects of general anesthesia (GA) and neuraxial anesthesia (NA) on the incidence of MI within 6 and 12 months after TURP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115025

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving TURP

Description

Inclusion Criteria:

  • Patients receiving TURP surgery (1998-2012)

Exclusion Criteria:

  • Patients without anesthesia records
  • Patients receiving both general and neuraxial anesthesia
  • Mortality within 12 months of TURP

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Without post-operative myocardial infarction
Patients without post-operative myocardial infarction after first admission for transurethral resection of the prostate
Other: general anesthesia or neuraxial anesthesia
With post-operative myocardial infarction
Patients with post-operative myocardial infarction after first admission for transurethral resection of the prostate
Other: general anesthesia or neuraxial anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative myocardial infarction
Time Frame: within 6 months after the first admission for TURP
Patients experienced myocardial infarction after transurethral resection of the prostate (TURP)
within 6 months after the first admission for TURP
Postoperative myocardial infarction
Time Frame: within 12 months after the first admission for TURP
Patients experienced myocardial infarction after transurethral resection of the prostate (TURP)
within 12 months after the first admission for TURP
Patient's age (year-old) that developed post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze age distribution of patients with post-TURP myocardial infarction
within 6 months after the first admission for TURP
Patient's age (year-old) that developed post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze age distribution of patients with post-TURP myocardial infarction
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed Diabetes Mellitus developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed Diabetes Mellitus rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed Diabetes Mellitus developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed Diabetes Mellitus rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed disorders of lipoid metabolism developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed disorders of lipoid metabolism rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed disorders of lipoid metabolism developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed disorders of lipoid metabolism rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed gout developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed gout rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed gout developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed gout rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed hypertension developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed hypertension rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed hypertension developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed hypertension rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed heart disease history developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed heart disease rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed heart disease history developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed heart disease rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed stroke history developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed stroke rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed stroke history developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed stroke rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed liver cirrhosis history developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed liver cirrhosis rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed liver cirrhosis history developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed liver cirrhosis rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed chronic obstructive pulmonary disease developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed chronic obstructive pulmonary disease rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed chronic obstructive pulmonary disease developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed chronic obstructive pulmonary disease rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed asthma developing post-TURP myocardial infarction
Time Frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed asthma rate in patients who had myocardial infarction after the surgery of TURP.
within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed asthma developing post-TURP myocardial infarction
Time Frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed asthma rate in patients who had myocardial infarction after the surgery of TURP.
within 12 months after the first admission for TURP

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients who had post-operative myocardial infarction after receiving general anesthesia for TURP
Time Frame: within 6 months after the first admission for TURP
Number of patients who had post-operative myocardial infarction after receiving general anesthesia for TURP
within 6 months after the first admission for TURP
Number of patients who had post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Time Frame: within 6 months after the first admission for TURP
Number of patients who had post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
within 6 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving general anesthesia for TURP
Time Frame: within 12 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving general anesthesia for TURP
within 12 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Time Frame: within 12 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
within 12 months after the first admission for TURP

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 104-6697B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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