Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001071718
Ethics application status
Approved
Date submitted
20/09/2013
Date registered
25/09/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Serum levels range of myocardial enzymes following urologic procedures.
Scientific title
The impact of urologic surgical procedures on the serum levels of myocardial enzymes: CPK, CK-MB, SGOT and LDH.
Secondary ID [1] 283275 0
None
Universal Trial Number (UTN)
Trial acronym
MESLeCUS (Myocardial Enzymes Serum Levels Changes in Urological Surgery)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urologic Surgical Procedures 290148 0
Condition category
Condition code
Renal and Urogenital 290542 290542 0 0
Other renal and urogenital disorders
Surgery 290570 290570 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Weeks
Description of intervention(s) / exposure
Measurement of the range of CPK, CK-MB, LDH and SGOT serum levels following urologic surgical procedures. The serum levels of these enzymes are going to be measured 24 hours pre- and 24 and 72 hours post-operatively.
Intervention code [1] 287999 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290567 0
To determine the changes in the levels of CPK (creatine phosphokinase), LDH (lactate dehydrogenase), SGOT (aspartate transaminase) enzymes and CK-MB (creatine phosphokinase MB) isoenzyme in healthy patients who undergo urologic surgery.
Timepoint [1] 290567 0
The serum activities of CPK, CK-MB, LDH and SGOT are going to be measured preoperatively (the day before surgery) and postoperatively (the first and the third postoperative day).
Secondary outcome [1] 304806 0
To compare the change of these enzymes in separated categories of procedures (open, endoscopic and laparoscopic)
Timepoint [1] 304806 0
The serum activities of CPK, CK-MB, LDH and SGOT are going to be measured preoperatively (the day before surgery) and postoperatively (the first and the third postoperative day).

Eligibility
Key inclusion criteria
1. Patients with no medical history of myocardial disease who undergo urologic surgical procedures, including open, endoscopic and laparoscopic surgery.
2. Age over 18 years old.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of coronary disease.
2. Evidence of acute myocardial infarction (AMI), diagnosed by clinical, laboratory (normal troponin levels) and electrocardiographical findings.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
13/01/2014
Date of last participant enrolment
Anticipated
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
4/01/2016
Sample size
Target
300
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 5435 0
Greece
State/province [1] 5435 0

Funding & Sponsors
Funding source category [1] 288014 0
Self funded/Unfunded
Name [1] 288014 0
Country [1] 288014 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 286735 0
None
Name [1] 286735 0
Address [1] 286735 0
Country [1] 286735 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43170 0
Dr Ioannidis Stavros
Address 43170 0
41 Ethnikis Aminis Street, Thessaloniki, 54643 . 1st urologic department of Gennimatas General Hospital of Thessaloniki.
Country 43170 0
Greece
Phone 43170 0
+302310963104
Fax 43170 0
Email 43170 0
stavros.ioannidis68@gmail.com
Contact person for public queries
Name 43171 0
Kampantais Spyridon
Address 43171 0
41 Ethnikis Aminis Street, Thessaloniki, 54643 . 1st urologic department of Gennimatas General Hospital of Thessaloniki.
Country 43171 0
Greece
Phone 43171 0
+302310963105
Fax 43171 0
Email 43171 0
kabspir@hotmail.com
Contact person for scientific queries
Name 43172 0
Kampantais Spyridon
Address 43172 0
41 Ethnikis Aminis Street, Thessaloniki, 54643 . 1st urologic department of Gennimatas General Hospital of Thessaloniki.
Country 43172 0
Greece
Phone 43172 0
+302310963105
Fax 43172 0
Email 43172 0
kabspir@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.