Comparison the effect of different Antrostomy and Sphenoidotomy size creation on postoperative mucosal edema and polyp growth rate in paranasal sinuses in patient with chronic rhinosinusitis and polyposis
Objectives: Evaluation of Antrostomy and Sphenoidotomy size on polyposis recurrence and mucosal edema after surgery. Design: This study is a clinical trial among 210 20-50 year old patients with chronic rhinosinusitis and polyposis candidate for surgery. Patients are classified in 3 groups by another resident randomly through sortition. Surgeon will be informed about the type of intervention in operating room. We have 70 patients in each group. Three groups include: 1:Antrostomy less than 1 cm and sphenoidotomy less than 0.5 cm 2:Antrostomy 1-2 cm and sphenoidotomy 0.5 -1 cm 3:Antrostomy 2-3 cm and sphenoidotomy 1-1.5 cm. All surgeries will be done in Amir Aalam hospital by one surgeon. Setting and Interventions: Measurement of size between two device around ostium will be done by a ruler. Seven to ten days after group selection and surgery, mucosal lymphedema will be assessed and polyposis recurrence will be evaluated monthly in first 3 months and every 6 weeks in next three months (up to 6 months) using endoscope in clinic. Edema grading will be: (Grade 1:no lymph edema, Grade2:lymph edema without obstruction, Grade 3:lymph edema with obstruction) Recurrence grading will be: (Grade1:no polyp growth, Grade2:polyp growth without obstruction, Grade3: polyp growth with obstruction). Inclusion criteria: 20-50 year old patients with chronic rhinosinusitis and polyposis in more than 3 sinuses including maxilla and sphenoid that need surgery after all diagnostic and therapeutic processes. Exclusion criteria: limited disease, collagenvascular disease, allergy, asthma, ASA sensitivity, immune disorder, smoking and toxin exposure and patients without tendency to join to this study. Primary outcome is recurrence rate and edema and secondary outcome is further surgeries.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090723936N1
Registration date:2017-06-16, 1396/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-16, 1396/03/26
Registrant information
Name
Mohsen Naraghi
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 1376
Email address
naraghim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of different Antrostomy and Sphenoidotomy size creation on postoperative mucosal edema and polyp growth rate in paranasal sinuses in patient with chronic rhinosinusitis and polyposis
Public title
Effect of sinuses ostium on post surgical outcomes.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:20-50 years old patients with chronic rhinosinusitis with polyposis in more than 3 sinuses including maxilla and sphenoid that need surgery after all diagnostic and therapeutic processes.
Exclusion criteria: limited disease; collagenvascular disease; allergy; asthma; ASA sensitivity; immune disorder; smoking and toxin exposure and patients without willingness to participate in research.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients are distributed in 3 groups like previously description.This is done randomly by third person that don't interfere in surgery.After choosing for surgery patients will refer to other room and are classified in 3 groups by another resident randomly and with balloting.Post operative endoscopy is done by second person that don't have any intervention in previous steps.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Floor 1, Tehran University of Medical Sciences, Ethics committee of Tehran University of Medical Sciences, in front of Avesta park, Azadi street, Tehran
City
Tehran
Postal code
Approval date
2017-04-05, 1396/01/16
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2034.
Health conditions studied
1
Description of health condition studied
chronic rhinosinusitis
ICD-10 code
J32.4
ICD-10 code description
Chronic pansinusitis
2
Description of health condition studied
sinonasal polyposis
ICD-10 code
J33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
edema
Timepoint
monthly in first 3 month and then every 6 weeks
Method of measurement
endoscopic view
2
Description
recurrence
Timepoint
monthly in first 3 month and then every 6 weeks
Method of measurement
endoscopic view
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Antrostomy size less than 1 cm and sphenoidotomy size less than 0.5 cm that is measured between two devices around ostium by a ruler.
Category
Treatment - Surgery
2
Description
Intervention group 2:Antrostomy size less than 1-2 cm and sphenoidotomy size 0.5-1 cm that is measured between two devices around ostium by a ruler.
Category
Treatment - Surgery
3
Description
Intervention group 3: Antrostomy size less than 2-3 cm and sphenoidotomy size 1-1.5 cm that is measured between two devices around ostium by a ruler.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Aalam Hospital in Tehran
Full name of responsible person
Dr Mehrnoosh Mousaviagdas
Street address
Endoscopy clinic, Tehran Amir Aalam Hospital, Saadi Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr Masood Younesian
Street address
Floor 6, Vice chancellor for research, Tehran University of Medical Sciences, Keshavarz boulevard,Tehran
City
Tehran
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran 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
Amir Aalam hospital
Full name of responsible person
Mehrnoosh Mousaviagdas
Position
Rhinologist
Other areas of specialty/work
Street address
Tehran Amir aalam hospital, Saadi street, Tehran
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
mehr_mousavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amir aalam hospital
Full name of responsible person
Mohsen Naraghi
Position
Professor of otorhinolaryngology
Other areas of specialty/work
Street address
Amir aallam hospital, Saadi street, Tehran
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
naraghim@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Amir aalam hospital
Full name of responsible person
Mehrnoosh Mousaviagdas
Position
Rhinology resident
Other areas of specialty/work
Street address
Amir aalam hospital, Saadi street, Tehran
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
mehr_mousavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)