Comparison of single versus sequential aortic side biting clamp for restoration of venoaortic anastomosis in coronary artery bypass surgery (CABG) patients
Comparison of single versus sequential aortic side biting clamp for restoration of venoaortic anastomosis in CABG patients.
Design
In the present clinical trial, which will be carried out in a parallel way, a total of 58 patients who will be undergoing coronary artery bypass surgery will be enrolled. Eligible patients are divided into two equal groups A and B.
Settings and conduct
Candidates for Coronary artery bypass graft surgery who visit Namazee Shiraz Hospital during the study will be included in the study if they are eligible and will be non-randomly assigned to the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 18 and 40 years old, Candidate for coronary artery bypass surgery with a diagnosis of coronary artery occlusion and Patient's informed consent.
Exclusion criteria: Positive history of valvular heart diseases and myocardial infarction, Patients who are at risk of cerebral embolism during ascending aorta clamping.
Intervention groups
Control group: In order to perform coronary artery bypass surgery, two surgeons who were similar in terms of surgery time and technique were selected. For the proximal anastomoses of the saphenous vein to the ascending aorta, simple partial clamp technique was used in the control group. In this method, a large lateral vascular clamp is placed on the ascending aorta And all the proximal anastomoses of the vein to the aorta are done by placing this same clamp.
Intervention group: In the Sequential partial aortic clamp method, a relatively small or medium vascular clamp was used, which closed a small amount of the aorta wall in each stage. At each stage, only one hole in the aorta wall were performed and after the end of each anastomosis, the clamp was opened and placed in another part of the aorta.
Main outcome variables
Cardiac arrhythmia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060750N1
Registration date:2024-03-03, 1402/12/13
Registration timing:retrospective
Last update:2024-03-03, 1402/12/13
Update count:0
Registration date
2024-03-03, 1402/12/13
Registrant information
Name
Reza Khajeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3739 8813
Email address
khaje_r@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
2014-06-22, 1393/04/01
Actual recruitment end date
2015-06-22, 1394/04/01
Trial completion date
2015-07-21, 1394/04/30
Scientific title
Comparison of single versus sequential aortic side biting clamp for restoration of venoaortic anastomosis in coronary artery bypass surgery (CABG) patients
Public title
Comparison of two methods of coronary artery bypass surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 40 years old
Candidate for coronary artery bypass surgery with a diagnosis of coronary artery occlusion.
Patient's informed consent
Exclusion criteria:
Positive history of valvular heart diseases
Positive history of recent myocardial infarction
Patients who were at risk of cerebral embolism during ascending aorta clamping
Age
From 18 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
58
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, Building number 3 of Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
IR.SUMS.REC.1393.6509
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Grafting
ICD-10 code
I25.810
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) without angina pectoris
Primary outcomes
1
Description
Troponin
Timepoint
before operation (base),just after operation,24 hours after operation.
Method of measurement
ز
2
Description
creatine phosphokinase
Timepoint
before operation (base),just after operation,24 hours after operation.
Method of measurement
elisa
3
Description
Cardiac arrhythmia
Timepoint
During the operation, after the operation.
Method of measurement
Cardiac monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In order to perform coronary artery bypass surgery, two surgeons who were similar in terms of surgery time and technique were selected. All surgeries were performed by open heart surgery, under cardiopulmonary pump and cardiac arrest, by injecting cold cardioplegic fluid in the ascending aorta. For the proximal anastomoses of the saphenous vein to the ascending aorta, simple partial clamp technique was used in the control group. In the simple partial clamp method, a large lateral vascular clamp is placed on the ascending aorta, and holes are created in the aorta wall with the number of vein clamps to the aorta by a punch device. All the proximal anastomoses of the vein to the aorta are done by placing this same clamp, and after the end of the last anastomosis, the vascular clamp is opened. While performing all the proximal anastomoses, the previously grafted areas are not supplied with blood
Category
Treatment - Surgery
2
Description
Intervention group: In the Sequential partial aortic clamp method, a relatively small or medium vascular clamp is used, which closes a small amount of the aorta wall in each stage. At each stage, only one hole in the aorta wall and only one anastomosis between the vein and the aorta were performed. After the end of each anastomosis, the clamp is opened and placed in another part of the aorta, and the next anastomosis is performed in the same way. Therefore, in this method, from the second anastomoses onwards, the previously grafted parts of the myocardium are supplied with blood.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee Hospital
Full name of responsible person
Reza Khajeh
Street address
Nemazee Hospital, Namazi Square,Zand Street.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
Nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hashem Hashempour
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Web page address
https://rde.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Khajeh
Position
Non-academic heart surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Al-Zahra(S) Hospital, Astana Three Roads, Siboye Blvd.
City
Shiraz
Province
Fars
Postal code
54937-71649
Phone
+98 71 3839 8113
Email
drrkhajeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khalil Zarrabi
Position
Associate Professor of Cardiovascular Surgery
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Al-Zahra(S) Hospital, Astana Three Roads, Siboye Blvd.
City
Shiraz
Province
Fars
Postal code
54937-71649
Phone
+98 71 3839 8113
Email
zarrabisx@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Saeedizade
Position
Research Assisstant
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Faghihi Hospital, Anesthesiology Department, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3628 1460
Email
saeedi.hamide@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD