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Comparison of fat versus Gelfoam in stapedotomy

Comparison of fat versus Gelfoam in stapedotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015082315496N17
Enrollment
200
Registered
2015-09-20
Start date
2012-05-18
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis. Otosclerosis involving oval window, nonobliterative

Interventions

Intervention 1: Control group underwent primary stapedotomy with use of fat for sealing of vestibulotomy site as routine. Intervention 2: Intervention group underwent primary stapedotomy with use of G
Treatment - Surgery
Control group underwent primary stapedotomy with use of fat for sealing of vestibulotomy site as routine.
Intervention group underwent primary stapedotomy with use of Gelfoam for sealing of vestibulotomy site.

Sponsors

Vice Chancellor for Research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criterion: 1) Patients who suffered from otosclerosis and undergone primary stapedotomy with use of fat versus Gelfoam for sealing of vestibulotomy site; 2) patients more than 18 years old. 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hearing results. Timepoint: 6 months after operation. Method of measurement: Observation by physician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSareh Roosta

Center for Development of Clinical Studies- Vice Chancellery of Research and Technology- Shiraz Univ

Roosta.Sareh@gmail.com+98 71 3612 5323

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026