Effects of intranasal amphotericin-B Irrigation on recurrence of massive nasal polyposis after endoscopic sinus surgery and comparison with nasal corticosteroid sprays
The purpose of the study is to determine the effect of intranasal amphotericin B solution compared to nasal corticosteroid spray on advanced nasal polyposis recurrence after endoscopic operation on sinus. The patients with corticosteroid dependency, the pregnant or nursing mothers, the mentally retarded or the people with verbal or behavioural disorders will be excluded. Those patients who display any adverse reaction or side- effects during treatment or those who don't complete the 4 month course of drug treatment and those who don't provide the researchers with a written permission will also be excluded. This is a random sampling study on 96 patients ( in 2 groups of 48) with more than 15 years old living in Guilan province who suffer serious polyposis of nose whose problem has been diagnosed through physical examination, diagnostic endoscopy & CT scan. All surgical operation are endoscopic along with correction of deviated septum. The day after operation when the patients are being discharged each patient in group A (intervention group) receives Amphotricine B (100 mg/ml) in distilled water kept in a dark bottle and each patient in group B (controls) receives the nasal Beclometazone Spray. The prescription and usage instructions are fully explained to the patients. The patients will be visited one week and one month after the operation followed by monthly visits to examine the nasal polyposis and renew the medication. At the end of the 4 months period the patient will fill in the questionnaire on respiratory problems after operation. Finally each patient will undergo a repeat diagnostic endoscopic operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706101138N1
Registration date:2010-09-30, 1389/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-30, 1389/07/08
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2012-02-23, 1390/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intranasal amphotericin-B Irrigation on recurrence of massive nasal polyposis after endoscopic sinus surgery and comparison with nasal corticosteroid sprays
Public title
Effects of intranasal amphotericin-B Irrigation on recurrence of massive nasal polyposis
Purpose
Treatment
Inclusion/Exclusion criteria
The study population consists of patients more than 15 years old residents of Guilan province who have extensive nasal polyposis and their diseases are diagnosed based on physical examination, diagnostic nasal endoscopy, and CT scan of paranasal sinuses. Only those patients who would complete the 4 months course of drug therapy and undergo the follow- up visits, will enter in the study. Those patients who are depended to corticosteroid drugs, pregnant or breast-feeder women, mental retard cases, or patients with speech or behavioral disorders will be excluded from the study.
Every patients who enter the study must fulfill informed consent.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Shahid Siadati st.- Rasht
City
Rasht
Postal code
Approval date
empty
Ethics committee reference number
5012
Health conditions studied
1
Description of health condition studied
nasal polyposis
ICD-10 code
J33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
recurrence of nasal poliposis
Timepoint
one week- one month- monthly up to 3 months
Method of measurement
clinical examination- diagnostic endoscopic
Secondary outcomes
1
Description
respiratory problems
Timepoint
end of 4th month
Method of measurement
questionnaire
Intervention groups
1
Description
amphotericin B solution
Category
Treatment - Drugs
2
Description
nasal Becklometazone Spray
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Shadman Nemati
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Research Vice
Street address
Rasht- Namjou st
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of medical sciences
Full name of responsible person
Dr shadman nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital
City
Rasht
Postal code
41396-37459
Phone
+98 13 1222 5242
Fax
Email
entrc@gums.ac.irnemati@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan university of medical siences
Full name of responsible person
Dr shadman nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)