Comparison of short-term complications of hemostatic powders and Surgicel on retrovesical bleeding during hysterectomy
Design
This clinical trial is phase3; randomized with software; without blinding in which 46 patient who are candidates for abdominal hysterectomy divided into two groups.
Settings and conduct
The research is carried out at Hajar Hospital in Shahrekord and there is no blinding
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient candidate for elective abdominal hysterectomy; age range 70-40 years.
Non inclusion criteria: pregnancy and taking ocp; history of systemic diseases ; inherited or acquired coagulation disorders; history of ischemic heart disease; history of taking anticoagulants and effective on bleeding ; smoking and alcohol; need to get blood and its products; need to have surgery again
Intervention groups
Intervention group 1: Surgicel and cauter are used topically during bleeding.
Intervention grop 2: ChitoHem and cauter are used topically during bleeding. All drugs are manufactured by Johanson & Johanson Company.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200316046787N1
Registration date:2020-03-24, 1399/01/05
Registration timing:registered_while_recruiting
Last update:2020-03-24, 1399/01/05
Update count:0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
shirin moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
mosavi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of short-term complications of hemostatic powders and surgicel on retrovesical bleeding during hysterectomy
Public title
Comparison of hemostatic powders and surgicel on behind bladder bleeding during hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidate for elective abdominal hysterectomy
Age range 40-70 years
Exclusion criteria:
Need to have surgery again
Need to get blood and its products
pregnancy and taking OCP
history of systemic diseases
history of inherited or acquired coagulation disorders
history of ischemic heart disease
history of taking anticoagulants and effective on bleeding
smoking and alcohol drinking
Age
From 40 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of the participants to the intervention 1 and 2 groups will be done using random allocation software. Then, some envelopes will be prepared according to the number of participants in the study. Then number 1 will be recorded on the first envelope, number 2 on the second envelope, and etc. The sequence of assignment of the participants will be determined by the software and each assignment will be put inside each envelope respectively. At the time of study running, the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention 1 or intervention 2 groups according to the option recorded inside the envelope.
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 Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences, Kashani boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.SKUMS.REC.1397.256
Health conditions studied
1
Description of health condition studied
hysterectomy
ICD-10 code
N85
ICD-10 code description
Other noninflammatory disorders of uterus, except cervix
Primary outcomes
1
Description
hematocrit
Timepoint
12 hours after surgery
Method of measurement
Complete blood count test (CBC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention grou 1:Surgicel and cauter are used topically during bleeding. All drugs are manufactured by Johanson & Johanson Company
Category
Treatment - Drugs
2
Description
Intervention group2: ChitoHem and cauter are used topically during bleeding. All drugs are manufactured by Johanson & Johanson Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital of Shahrekord
Full name of responsible person
Lobat Jafarzadeh
Street address
Hajar Hospital affiliated to Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jafarzade@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Mehraban Sadeghi
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences ,Kashani boulevard, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jafarzade@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Lobat Jfarzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
jafarzade@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lobat Jafarzade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
818718791
Phone
+98 38 3222 0016
Email
jafarzade@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lobat Jafarzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
009832220016
Email
jafarzade@skums.ac.ir
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