This is a prospective, controlled, randomized, clinical trial and aim of this study is evaluation of effect of spray cryotherapy (SCT) on management of healing in patients with nasal polyposis undergoing functional endoscopic sinus surgery (FESS). Inclusion criteria: patients with bilateral nasal polyposis who have indication for functional endoscopic sinus surgery; age between 18 to 70 years. Exclusion criteria: The patients with severe complications; People who do not have the consent to participate in the study; do not follow up. The sample size is 40 patients. Patients are randomly divided into two parallel groups as intervention and placebo groups. The randomization is doing with a randomization software. Intervention group are under treatment with SCT and placebo group is under treatment with normal saline spray after FESS. Recovery will be evaluated in both groups according to pre-prepared questionnaire after 12 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092012782N19
Registration date:2017-10-08, 1396/07/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-08, 1396/07/16
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2016-12-31, 1395/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome of usage of spray cryotherapy on management of healing in patients with nasal polyposis undergoing functional endoscopic sinus surgery.
Public title
Effect of spray cryotherapy on treatment of nasal polyposis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with bilateral nasal polyposis who have indication for functional endoscopic sinus surgery; age between 18 to 70 years.
Exclusion criteria: The patients with severe complications; People who do not have the consent to participate in the study; do not follow up.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Approval date
2017-03-21, 1396/01/01
Ethics committee reference number
IR.MUI.REC.1396.30430
Health conditions studied
1
Description of health condition studied
Nasal Polyposis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Recovery
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Prepared questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Under treatment with Cryotherapy spray after endoscopic sinus surgery
Category
Treatment - Drugs
2
Description
Placebo group: Normal saline spray after endoscopic sinus surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Ahmad Rezaeian
Street address
Amin Hospital, Isfahan, Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
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,Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Rezaeian
Position
Otorhinolaryngologist/ Assistant professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3265 1574
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Rezaeian
Position
Assistant professor of Otorhinolaryngology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for research/Master of Science
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)