Status
Conditions
Treatments
About
the troponin level and ECGs pre and post operative will be used to determined prevalence of myocardial injury among patients undergoing gastrointestinal surgery
Full description
AIM:
The aim of this study is to determine the prevalence of myocardial injury in gastrointestinal surgery patients and to establish baseline data to allow evaluation of the potential benefit of RIPC (remote ischemic preconditioning) in these patients
Significance:
In available literature was one study including 51 patients that focused on postoperative arrhythmias in colorectal surgery . We think this study is important to establish more specifically the prevalence of myocardial injury in this cohort of patients so we can measure in our future research if RIPC or any other protective method could produce significant effect.
Study Design:
Prospective Observational cohort Study
Study Objectives:
To determine the prevalence of myocardial injury in patients undergoing gastrointestinal surgery
Patients and Locations:
Patients older than 18 years undergoing major resectional gastrointestinal surgery in Galway University Hospitals (UCHG, Mayo university Hospital), The Midland Regional Hospital, Tullamore and Letterkenny University Hospital will be asked to join the study and will considered eligible after informed consent and information handouts provided.
Protocol:
After informed consent patients' pre-op demographic data, co-morbidities, bloods including troponin and ECG will be recorded. Serum troponin levels will be measured daily for the first 72 hours and a 12-lead electrocardiogram will be performed at 48 hours post-surgery. There will be 1 year flow up for candidates
Data Handling:
The data for each hospital will be kept locally and patients will be allocated numbers for later data analysis. The pooled data will be analyzed using a secure computer in an NUI Galway research facility building. No patients' name or any other identifier will be associated with this data except for their study number assigned earlier
Primary Outcome:
Prevalence of myocardial injury by comparing pre and post-op troponin and ECGs. The diagnosis of myocardial injury will be determined by a cardiologist after examining troponin and ECGs results using SAVES trial criteria (5).
Perioperative Myocardial injury will include silent myocardial infarctions as determined by the study cardiologist upon examination of study ECGs and troponin results. The diagnosis of a myocardial injury will require the presence of at least two of the following:
Other Data:
Exclusion Criteria
Sample Size:
This is a prospective study to determine the incidence of myocardial injury in gastrointestinal surgical patients. There are no existing data upon which to base a sample size calculation. We estimate that data from 100 patients should provide a sufficient sample size to generate a reasonably robust incidence estimate. However, if the included centers recruit more patients they will be included in our analysis
Statistical Analysis:
Statsdirect will be used for analysis of the study results Budget No additional budget for the study will be needed as tests required routinely requested within the study clinical setting. The analysis and management of the study will be performed by clinical research fellow funded by National University of Ireland Galway
Conflict of interest:
Study team declare no conflict of interest
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal