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Effect of topical furosemide on Rhinosinusal polyposis Relapse: A Triple Blinded Randomized Controlled Trial

Protocol summary

Summary
Study design: effect of topical furosemide on rhinosinusal polyposis relapse. A triple blinded randomized controlled trial، placebo-controlled. Plan: patients referred to Besat hospital clinic with chronic rhinosinositis and sinunasal polyposis(according to AAO-HNS) who have not responded to medical therapy, conscious to plan. Perform: patients randomly will be divided to intervention and control groups. All the patients will use preoperatively ,prednisolon tab, cefixime tab, and fluticasone spray for 10 days and then will go on operation(Fess and polypectomy). The intervention group will receive cefixime tab (10 days),fluticasone spray(6 months) and intranasal furosemide spray(2 months) after surgery. 6 months post operation and the control group will receive cefixime tab(10 days), fluticasone spray(6 months) and intranasal placebo spray(2 months) after surgery .for both groups before and after 6 months, PNS CT Scan scoring,SNOT-22,VAS,and Meltzer grading will be recorded. Intervention: Furosemide spray (6.6 mmol/L) 300 mcg each nostril/day (2puff twice for 2 months) after surgery. Study outcomes are: polyposis, burning sensation), epistaxis and hypersensitivity. Inclusion criteria: patients referred to besat hospital clinic with chronic rhinosinositis and sinunasal polyposis (according to AAO-HNS) who have not responded to medical therapy and 18-60 years old and candidate for FESS. Exclusion criteria: pregnancy; history of hypertension and cardiac diseases; hypokalemia; history of tinnitus; history of sensory neural hearing loss and hypersensitivity to Furosemide. Sample size: 82.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403143186N5
Registration date: 2014-05-28, 1393/03/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-28, 1393/03/07
Registrant information
Name
Farnaz Hashemian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 9001
Email address
hashemian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical furosemide on Rhinosinusal polyposis Relapse: A Triple Blinded Randomized Controlled Trial
Public title
Effect of topical furosemide on nasal polype relaps
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients referred to Besat hospital clinic with chronic rhinosinusitis (according to AAO-HNS) who have not responded to medical therapy and age with 18-60 years old. Exclusion criteria: pregnancy; history of hypertension، cardiac diseases، hypokalemia; history of tinnitus; history of sensory neural hearring loss and hypersensitivity to furosemide.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Shahid Fahmideh street, Hamedan university of medical science
City
Hamedan
Postal code
65178
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
16/35/9/4194 /پ/د

Health conditions studied

1

Description of health condition studied
Nasal polyposis
ICD-10 code
J33
ICD-10 code description
nasal polyp, unspecified

Primary outcomes

1

Description
Nasal and paranasal sinus polyposis
Timepoint
Before intervention,1 month, 3 months, 6 months after intervention
Method of measurement
SNOT-22 questionnaire, PNS CT scan scoring, VAS, Meltzer grading

Secondary outcomes

1

Description
Burning sensation
Timepoint
1 month, 3 months, 6 months after intervention
Method of measurement
Questionnaire

2

Description
Epistaxis
Timepoint
1 month, 3 months, 6 months after intervention
Method of measurement
Questionnaire and physical examinatin

3

Description
Hypersensitivity
Timepoint
1 month, 3 months, 6 months after intervention
Method of measurement
Questionnaire and physical examinatin

Intervention groups

1

Description
Intervention group: Furosemide/ spray/ twice a day/ 2puffs in each nostril for 2 months.
Category
Prevention

2

Description
Control group: placebo/ spray/ twice a day/ 2 puff in each nostril for 2 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital, ENT clinic
Full name of responsible person
Farnaz Hashemian
Street address
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Tavilani Heydar
Street address
Shahid Fahmideh street, Hamedan University of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, Shahid Beheshti Blvd,Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir; hashemianf@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, shahid beheshti Blvd. Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0047
Fax
Email
Hashemian@umsha.ac.ir; hashemianf@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital ,Shahid Beheshti Blvd. Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0047
Fax
Email
hashemian@umsha.ac.ir; hashemianf@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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