Comparison the effect of two left internal mammary artery harvesting techniques skeletonization and pedicle on post coronary artery bypass surgery pain and bleeding ;a Randomized Double Blind Clinical Trail
A total of 60 patients undergoing elective, Coronary artery bypass graft requiring Left internal mammary artery harvest were screened for eligibility and were included into the study. Emergency surgery, a history of cardiac surgery, a history of receiving medication with antiplatelet agents, a left ventricular ejection fraction less than 20%, preoperative renal dysfunction, preoperative hepatic dysfunction, electrolyte imbalance, Inability to return for follow-up visits, premature mortality, neurological complications, and use of intra-aortic balloon pump were the exclusion criteria. The patients were categorized into two equal groups by computer: skeletonized harvesting method and pediculate harvesting method. All post-operative assessment were performed by the medical staff who were blinded to the group of the patients. post-operative bleeding were evaluated in the first 24 hours postoperatively. Each patient's pain was assessed by visual analogue scoring at the third day post oprative and at 1-year follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121320112N5
Registration date:2016-01-14, 1394/10/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-14, 1394/10/24
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two left internal mammary artery harvesting techniques skeletonization and pedicle on post coronary artery bypass surgery pain and bleeding ;a Randomized Double Blind Clinical Trail
Public title
Comparison the effect of two left internal mammary artery harvesting techniques skeletonization and pedicle on post coronary artery bypass surgery pain and bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: elective Coronary Artery Bypass Graft requiring; American association of anesthesiologist class 2 and 3; age between 30 to 70 years old .
exclusion ceraiteria: Emergency surgery; a history of cardiac surgery; a history of receiving medication with antiplatelet agents; a left ventricular ejection fraction less than 20%; preoperative renal dysfunction ; preoperative hepatic dysfunction; preoperative electrolyte imbalance; Inability to return for follow-up visits; premature mortality; neurological complications; and use of intra-aortic balloon pump.
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand univercity of medical siences
Street address
Birjand, South Khorasan, Ghafariavn Avenue, Birjand University of Medical Sciences and Health Services
City
Birjand
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
1393-09-05
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
pain
Timepoint
the third day post opration
Method of measurement
Visual Analuge Scale
2
Description
Post oprative bleeding
Timepoint
24 hour post opration
Method of measurement
chest tube bottle
Secondary outcomes
1
Description
pain
Timepoint
1 year follow-up
Method of measurement
visual analogue scoring
Intervention groups
1
Description
left internal mammary artery harvesting techniques pedicle in coronary artery bypass surgery
Category
Treatment - Surgery
2
Description
left internal mammary artery harvesting techniques skeletonization in coronary artery bypass surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Dr Pooya Derakhshan
Street address
Birjand, Taleghani Blvd, Emam Reza Hospital
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University Of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Vice chancellor for research,Birjand University of Medical Sieance,Birjand
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of medical sience
Full name of responsible person
Dr Pooya Derakhshan
Position
assitant professor
Other areas of specialty/work
Street address
no. 51, sasan St., Velnenjak ST.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Univecity of medical siences
Full name of responsible person
Pooya Derakhshan
Position
Assistant professor
Other areas of specialty/work
Street address
Rasol Akram hospital, Satarkhan St.
City
Thran
Postal code
Phone
+98 21 6435 2326
Fax
Email
pooyaderak@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant professor
Other areas of specialty/work
Street address
Rasool Akram Hospital, Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
pooyaderakh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)