Comparison hearing result between fluoroplastic (Teflon) Causse Loop Piston and titanium Soft Clip in patient underwent stapedotomy in 2015 in Dastgheib university Hospital
This is an interventional study.Goal of study is comparing hearing improvement in patients with otosclerosis who underwent primary stapedotomy with teflon-piston or softclip prosthesis . This is a randomized controlled trial in a single center (Dastgheib hospital) which is not blind. Statistician does not know which prosthesis was used for each patient. Study population is 120 patients divided in two groups by block randomization; 63 patients in teflon piston group and 57 patients in soft clip group. Inclusion criterion: Patients who suffered from otosclerosis and undergone stapedotomy with each of prosthesis as intervention. Exclusion criteria: Patients, who underwent stapedectomy and/or revision stapedotomy, Patients who underwent stapedotomy for reasons other than otosclerosis, patients with inadequate postoperative follow-up. preoperative physical exam and audiometry will be done for all patients. All operations will be done by one surgeon,under local anesthesia, and with transcanal approach. Patients will be followed at least 6 months.Data gathering will be done between july 2015 and july 2016. In 6 months postoperative follow up physical exam and audiometry will be done. Preoperative and postoperative air conduction (AC) and bone conduction (BC) values at 500,1000,2000,3000 Htz will be recorded. Air-bone gap will be calculated. Speech reception threshold (SRT) and speech discrimination score (SDS) is recorded too.To compare hearing improvement in two group as primary outcome, these preoperative and postoperative audiometric findings will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012115496N5
Registration date:2015-09-11, 1394/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-11, 1394/06/20
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
shiraz university of medical science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison hearing result between fluoroplastic (Teflon) Causse Loop Piston and titanium Soft Clip in patient underwent stapedotomy in 2015 in Dastgheib university Hospital
Public title
comparing hearing result between two prosthesis teflon-piston and softclip
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patients who suffered from otosclerosis and underwent stapedotomy with fluoroplastic (teflon) Causse Loop Piston prosthesis or titanium soft clip.
exclusion criteria:: 1) All Patients who underwent stapedectomy; 2) Revision cases; 3) Patients who underwent stapedotomy for reasons other than otosclerosis, such as: congenital stapes fixation, malleus head fixation, trauma, chronic otitis media, and tympanosclerosis plaque; 4) Inadequate follow-up(less than 6 months) after surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran, Islamic Republic