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
This study aims to investigate the clinical benefits and success rates of endoscopy and microscopy surgical approaches of tympanoplasty in patients with chronic otitis media.
Design
A randomized clinical trial with an open-label design with two randomized parallel intervention groups on 34 patients. Simple randomization will be used according to computerized generated numbers using random allocation software.
Settings and conduct
Place of study: This study will be conducted at Urmia Imam Khomeini Hospital in Urmia. Study population: The patients who will be candidates for tympanoplasty surgery due to chronic otitis media. Blinding won't be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patients with a mucoid type of chronic suppurative otitis media; the presence of conductive hearing loss with no sensorineural hearing loss; good general physical condition; no evidence of infection in nose, throat, and paranasal sinuses
Non-inclusion criteria: smokers; participants with cholesteatoma; participants with otosclerosis; diabetes; individuals with cardiovascular disease and chronic liver or renal diseases
Intervention groups
Intervention group 1: The microscopic group, in which an incision will be executed behind the ear with subsequent entry into the canal. The Lempert method will be served as the basis for the lifting of the tympanomeatal flap. Intervention group 2: The endoscopic group that the incisions for this approach will be made approximately 5 to 6 millimeters lateral (to the side) to the tympanic annulus in the posterior part of the external auditory canal (EAC). By lifting a tympanomeatal flap, the surgeon will be able to visualize the middle ear cavity.
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
Public title
The success rate of two surgical approaches of Tympanoplasty
Purpose
Diagnostic
Inclusion/Exclusion 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:
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
Age
From 14 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients will be done by simple randomization according to computerized generated numbers using random allocation software that half of the participants will be assigned to the endoscopy group based on odd numbers and the other half will be assigned to the microscopic group based on even numbers.
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
Research Ethics Committees of Urmia University of Medical Sciences
The graft success rate will be assessed between 3-6 months postoperatively.
Method of measurement
Endoscopic assessment
2
Description
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).
3
Description
Duration of surgery
Timepoint
The duration of the surgery will be measured intraoperatively.
Method of measurement
Using a chronometer (in minute)
Secondary outcomes
empty
Intervention groups
1
Description
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 microscopic approach, an incision will be executed behind the ear with subsequent entry into the canal. The Lempert method will be served as the basis for the lifting of the tympanomeatal flap.
Category
Diagnosis
2
Description
Intervention group 2: The endoscopic group (the new approach) will be employed an endoscopic system manufactured by Karl Storz in Tuttlingen, Germany. Rigid endoscopes with either 0- or 30-degree angles and diameters of 3.0- or 4.0-mm, and lengths of 11 or 16 cm (also from Karl Storz) will be used for the procedure. The incisions for this approach will be made in the posterior part of the EAC approximately 5 to 6 mm lateral to tympanic annulus, perpendicular to the TM tympanic at both the superior and the inferior ends of the first incision.