1.Investigating the condition of bleeding surgery, 2- Investigating the condition of the quality of surgical field
Design
Clinical practice with a control group, community based and pragmatic, double-blind, randomized
Settings and conduct
The present study is a double-blind clinical trial on 56 patients with chronic rhinosinusitis requiring sinus endoscopic surgery which will be held in Bushehr’s Hospital.
Blindness will take place by random allocation by an operating room technician.
For random allocation of individuals a gender-based minimization method is going to use in form of balanced blocks.the surgeon and the person assessing will get full blindness on the study , only the nurse who is supposed to perform mesh placing will be fully informed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic rhinosinusitis that did not respond to drug therapy; age between 18 to 60 years old; hemoglobin above 10g/dl; the value of Bleeding time (BT), Prothrombin time (PT), Partial thromboplastin time (PTT), International normalized Ratio (INR) should be normal. Non inclusion criteria: cardiovascular disorder; taking anticoagulant drug; Inherited anticoagulant drug; Allergy to drugs; renal failure; hematuria; cirrhosis; choronic disease such as diabetes and hypertension; pregnancy; nasal tumor; color blindness.
Intervention groups
Intervention group: a mesh soaked in a mixture of phenylephrine 0.05 %vol. and transamic acid at the dose of 15 mg/kg for 10 minutes will be placed in the nose. Control group: a mesh soaked in a phenylephrine will be used.
Main outcome variables
Bleeding during surgery, quality of surgical field
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180730040640N1
Registration date:2018-09-30, 1397/07/08
Registration timing:registered_while_recruiting
Last update:2018-09-30, 1397/07/08
Update count:0
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Reza mazarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3484 3924
Email address
r.mazarei@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Topical Tranexamic Acid on Bleeding Reduction during Functional Endoscopic Sinus Surgery in choronic rhinosinousitis patient
Public title
The Effect of Topical Tranexamic Acid in endoscopic sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic rhinosinusitis that don't not respond to drug therapy and require sinus surgery
The age of the participant(s) must be between 18 and 60 years old
The amount of hemoglobin of the participant should be above 10 g/dl
the amount of Bleeding time (BT), Prothrombin time (PT), Partial thromboplastin time (PTT), International normalized Ratio (INR) should be normal in participants.
Exclusion criteria:
Participants with cardiovascular disorders.
Participants who have coagulation disorders or who are taking anticoagulant medicines(drugs)
Participants with inherited coagulation disorders such as thrombophilia.
Participants with coagulation disorders history in the past.
Participants who have a history (record) of allergy to any drug(s) in the past.
Participants who have been suffering from renal deficiency in the past.
Participants with cirrhosis.
Participants with chronic diseases, such as diabetes and hypertension.
Participants who are pregnant.
participants with malignant nasal tumor.
Color blindness
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of participants (individuals), a gender-based minimization method and balanced blocks will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind clinical trial on 56 patients with chronic rhinosinusitis requiring sinus endoscopic surgery which will be held in Bushehr’s Hospital.Blindness will take place by random allocation by an operating room technician.For random allocation of individuals a gender-based minimization method is going to use in form of balanced blocks.the surgeon and the person assessing will get full blindness on the study , only the nurse who is supposed to perform mesh placing will be fully informed.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Bushehr University of Medical Sciences
Street address
Sabzabad Blvd, Salman Farsi street, Reishehr
City
Bushehr
Province
Boushehr
Postal code
7517933755
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.BPUMS.REC.1397.040
Health conditions studied
1
Description of health condition studied
Bleeding control and improvement of the quality of surgical field in sinus endoscopic surgery of those who need surgery that did not respond to drug therapy.
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
bleeding during surgery
Timepoint
At 15th, 30th and 45th minute after intervention
Method of measurement
The Boezaart measuring scale
2
Description
Surgeon's satisfaction with quality of surgical field.
Timepoint
At 15th, 30th and 45th minute after intervention
Method of measurement
Likert scale plan for satisfaction
Secondary outcomes
1
Description
blood pressure
Timepoint
every 15 minutes after start of surgery
Method of measurement
heart monitoring
2
Description
bleeding volume
Timepoint
every 15 minutes after start of surgery
Method of measurement
suction device
3
Description
pulse rate
Timepoint
every 15 minutes after start of surgery
Method of measurement
heart monitoring
Intervention groups
1
Description
Intervention group: a group of 56 patients with chronic rhinosinusitis, requiring sinus endoscopic surgery was obtained. For preoperation patient , a mesh soaked in a mixture of phenylephrine 0.05 %vol. and transamic acid at a dose of 15 mg / kg for 10 minutes will be placed in the nose(nasal cavity) of the patient by an operating room technician, then it will get extracted and operation(procedure) will begin. Bleeding rate will measure according to the Boezaart grade scale and the surgeon's satisfaction is going to measure based on the Likert scale.
Category
Treatment - Surgery
2
Description
Control group: This group is consist of 56 patients with chronic rhinosinusitis, requiring surgical endoscopy of the sinus. In this group, a mesh soaked in a solution of 0.05%vol. of phenylephrine for 10 minutes will be placed in the nose(nasal cavity) of the patient by an operating room technician, then the mesh will get extracted and operation(procedure) begins. Bleeding rate would measure according to the Boezaart grade scale and the surgeon's satisfaction will measure based on the Likert scale.Clinical practice with a control group, community based and pragmatic, double-blind, randomized
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalije Fars hospital
Full name of responsible person
Atefehe Sfandiari
Street address
Taleghani Avenue
City
Boushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5374
Fax
+98 77 3345 5390
Email
atefehesfandiari88@gmail.com
Web page address
http://www.mpgh.bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Sabzabad Blvd, Salman Farsi street, Reishehr
City
Boushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
+98 77 3345 0178
Email
Khamisipour@bpums.ac.ir
Web page address
http://www.bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?