Comparison of the recovery rate after open heart surgery in children with minimally invasive incisions and complete sternotomy
Design
Clinical trial without a control group, with parallel groups, single-blind, randomized, phase 2 on 74 patients. The website www.Randomization.com was used for randomization (online randomization). For this purpose, a simple randomization model was used.
Settings and conduct
The participants in this blind randomized clinical trial study (the patient and his parents do not know about the method chosen for him) will be 74 children aged 8-18 years who are candidates for open heart surgery. Identification of these patients will be done after visiting the heart clinic or the emergency room of Modares Hospital.
Participants/Inclusion and exclusion criteria
1. Patients undergoing valve replacement or septal defects
2. Absence of inflammatory, infectious, autoimmune, malignant, kidney, liver or thyroid diseases and diabetes
3. No previous surgery in the chest area
Intervention groups
Group 1: patients under complete sternotomy
Group 2: Patients undergoing minimally invasive incisions (mini-sternotomy and thoracotomy)
Main outcome variables
The primary outcome of this study is the level of pain and the amount of analgesic used in patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230626058586N4
Registration date:2024-04-09, 1403/01/21
Registration timing:registered_while_recruiting
Last update:2024-04-09, 1403/01/21
Update count:0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Nasim Sohrabifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 229 6766
Email address
nasimsohrabifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post operative recovery rate after open heart surgery in children under minimally invasive incisions and full sternotomy
Public title
Effect of incision type in recovery after heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing valve replacement surgery or septal defects
Exclusion criteria:
Having previous surgery in the chest area
Inflammatory, infectious, autoimmune and malignant diseases, kidney, liver or thyroid diseases and diabetes
Age
From 8 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The website www.Randomization.com was used for randomization (online randomization). For this purpose, a simple randomization model was used. The randomization unit was individual and on this website, after specifying the number of intervention groups, which were two groups, and the required number in each of these groups, the website provided us with a random table of repetitions that represented the patient number. To hide the random allocation, central randomization was used. In this method, a random sequence is placed in the possession of an individual or a specific center, and sampling is done in one or more centers at the same time. Based on the order in which the participants entered the study, the researcher contacted the relevant center and asked about the random assignment of the participants to a special group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single-blinded and patients and their parents (or their caregivers in the ICU) will be unaware of the type of incision performed. Up to 48 hours after the operation, the incision site is covered by a bandage, and the patient and parents do not see the type of incision. Although before the surgery, they will be informed that one of the types of incision will be chosen for them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran.
City
Tehran
Province
Tehran
Postal code
1995825466
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.SBMU.MSP.REC.1402.619
Health conditions studied
1
Description of health condition studied
Open heart surgery
ICD-10 code
G89.12
ICD-10 code description
Acute post-thoracotomy pain
Primary outcomes
1
Description
The level of pain and consumption of analgesic in patients
Timepoint
0-6 hours after surgery, 24-48 hours after surgery, upon discharge
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Incision site infection
Timepoint
0-6 hours after surgery, 24-48 hours after surgery, upon discharge
Method of measurement
Physical examination and lab tests.
2
Description
dehiscence of the wound
Timepoint
0-6 hours after surgery, 24-48 hours after surgery, upon discharge
Method of measurement
physical examination
Intervention groups
1
Description
Intervention group: full sternotomy
Category
Treatment - Surgery
2
Description
Intervention group: minimally invasive incisions
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ramin Baghayi Tehrani
Street address
Shahid beheshti University of medical sciences Research Vice-Chancellor, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjoo Blvd., Volenjak St., Tehran.
City
Tehran
Province
Tehran
Postal code
199852468
Phone
+98 21 2387 1524
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Position
faculty member (associate professor)
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Position
faculty member (associate professor)
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital,
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ramin Baghayi Tehrani
Position
faculty member (associate professor)
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cardiovascular Research Center, Saadat Abad Shahid Modares Hospital
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 938 229 6766
Email
nasimsohrabifar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available