The success rate of two surgical approaches of Tympanoplasty

Evaluation of the efficacy of endoscopic ear surgery compared to microscopic method on pain severity and graft success rate among patients with chronic otitis media: a randomized clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221002056073N2

Enrollment

Registered

2023-07-18

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Chronic Otitis media. Chronic serous otitis media

Interventions

Intervention 1: Intervention group 1: In the microscopy group (a common approach) the Opmi Vario S88 microscope from Carl Zeiss in Oberkochen, Germany will be used for investigation. In the microscopi

Eligibility

Sex/Gender

All

Age

14 Years to 55 Years

Inclusion criteria

Inclusion criteria: The patients with a mucoid type of chronic suppurative otitis media Presence of conductive hearing loss with no sensorineural hearing loss in patients Patients with good general physical condition Patients with no evidence of infection in nose Patients with throat and paranasal sinuses undergoing surgery for the first time for the concerned ear

Exclusion criteria

Exclusion criteria: Individuals younger than14 years of age and older than 55 years Smokers Participants with contralateral ear disease Patients with cholesteatoma Patients with otosclerosis Patients with tympanosclerotic plaque or granulation tissue in the middle ear Patients undergoing simultaneous mastoid surgery Revision cases and associated poor general condition Those with preoperative medical issues such as asthma Diabetic patients Patients with cardiovascular disease Patients with chronic liver or renal diseases

Design outcomes

Primary

Measure	Time frame
Graft success rate. Timepoint: The graft success rate will be assessed between 3-6 months postoperatively. Method of measurement: Endoscopic assessment.;Pain severity. Timepoint: Pain severity will be assessed immediately after surgery and one day after surgery. Method of measurement: Pain severity will be evaluated and recorded by the patient using an 11-point numerical rating scale (NRS-11, range 0 to 10).;Duration of surgery. Timepoint: The duration of the surgery will be measured intraoperatively. Method of measurement: Using a chronometer (in minute).	—

Measure

Time frame

Graft success rate. Timepoint: The graft success rate will be assessed between 3-6 months postoperatively. Method of measurement: Endoscopic assessment.;Pain severity. Timepoint: Pain severity will be assessed immediately after surgery and one day after surgery. Method of measurement: Pain severity will be evaluated and recorded by the patient using an 11-point numerical rating scale (NRS-11, range 0 to 10).;Duration of surgery. Timepoint: The duration of the surgery will be measured intraoperatively. Method of measurement: Using a chronometer (in minute).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Samarei

Oroumia University of Medical Sciences

samareireza@gmail.com+98 44 3345 9538

Outcome results

None listed

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