Comparison of satisfaction and bleeding of Triamcinolone impregnated gelfoam with Triamcinolone impregnated Surgicel in nasal dressing after endoscopic sinus surgery in patients with polyposis
Comparison of satisfaction and bleeding of Triamcinolone impregnated gelfoam with Triamcinolone impregnated Surgicel in nasal dressing after endoscopic sinus surgery in patients with polyposis.
Design
a randomized, double blinded, controlled clinical trial
Settings and conduct
Amiralam hospital, endoscopic sinus surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Age between 18-65 years
2- Bilateral polyposis
3- Diagnosis of chronic rhinosinusitis based on EPOS 2012.
4-Chronic rhinosinusitis resistant to medical therapy
Exclusion criteria:
1.Any systemic or reheumatologic diseases related to nasal disorders like cystic fibrosis, wegner, sarcoidosis
2.Other pathologies than polyposis such as inverted papilloma or neoplasms
Intervention groups
One group of patients with chronic rhinosinusitis with bilateral polyposis received Triamcinolone impregnated gelfoam as a nasal dressing and other group received Triamcinolone impregnated Surgicel as a nasal dressing.
Main outcome variables
The rate of satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150907023936N2
Registration date:2018-08-11, 1397/05/20
Registration timing:registered_while_recruiting
Last update:2018-08-11, 1397/05/20
Update count:0
Registration date
2018-08-11, 1397/05/20
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
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of satisfaction and bleeding of Triamcinolone impregnated gelfoam with Triamcinolone impregnated Surgicel in nasal dressing after endoscopic sinus surgery in patients with polyposis
Public title
Comparison of endoscopic findings of Triamcinolone impregnated gelfoam with Triamcinolone impregnated Surgicel in nasal dressing after endoscopic sinus surgery in patients with polyposis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years old
Bilateral polyposis
Diagnosis of chronic rhinosinusitis based on EPOS 2012
Chronic rhinosinusitis resistant to medical therapy
Exclusion criteria:
Any systemic or reheumatologic diseases related to nasal disorders like cystic fibrosis, wegner, sarcoidosis
Other pathologies than polyposis such as inverted papilloma or neoplasms
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Each side of nose will be assessed as an intervention group
Randomization (investigator's opinion)
Randomized
Randomization description
Computer assisted random allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
Post operative assessment about patient complaints, will be done by a resident or fellowship resident who is blind to the type of dressing. Also, the patients themselves are also blind about the dressing's type.
Placebo
Not used
Assignment
Parallel
Other design features
In included patients Lund-Mackay and Lund-Kennedy score will be assessed pre-operatively. All the patients will be operated by one surgeon.Randomly, one side of the nose well be dressed with Triamcinolone impregnated gelfoam and the other will be dressed by Triamcinolone impregnated Surgicel. The post operative assessment about patient complaints, will done by a resident or fellowship resident who is blind to the type of dressing.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd