It is a comparison between microscopic and endoscopic tympanoplasty

Not yet recruiting

Conditions: Central perforation of tympanic membrane, (2) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified,

Registration Number: CTRI/2022/11/047120

Lead Sponsor: ROHILKHAND MEDICAL COLLEGE AND HOSPITAL

Brief Summary: Chronic otitis media is the inflammation of mucous membrane of middle ear cleft. It presents with permanent abnormality in pars tensa or flaccida. According to WHO 65-330 million people world wide suffer from CSOM of whom 50% suffer from hearing impairement and 28000 people die per year. The hearing impairement is usually preventable if preferred intervention is taken on time . The management of chronic otitis media depends on the type of chronic otitis media .

The main aim of surgery in chronic otitis media is to decrease hearing disability in the patient.

Tympanoplasty is the surgery of choice amongst mucosal type of chronic otitis media. Tympanoplasty is a procedure to remove disease from middle ear and reconstruct hearing with or without tympanic membrane grafting.

Conventionally Microscopic tympanoplasty is being used and still in practice for surgery for TM perforations . But since the introduction of endoscopes in the 1990s ,endoscopic tympanoplasty is emerging as an alternative for microscopic tympanoplasty. Microscopes provide the benefit of using both hands to perform surgery but with the limitation of narrow view of the surgical field and inability to access deeper areas which is possible with the use of endocopes. Though it suffers from this limitation , the use of only one hand in endoscopic surgery limits endoscope use as there is hesitancy among surgeons regarding efficacy and safety of endoscopes along with the need of special training and experience to use endoscopes.

Microscopic tympanoplasty is performed through postauricular incision which increases hospital stay and discomfort of the patient whereas the use of endoscopes have reduced surgery time , hospital stay and post operative pain due to its minimally invasive procedure.

The concerns regarding depth perception , steeper learning curve and chance of injury by the light source , fogging of the lens during surgery, is a limitation to endoscopic surgery.

Since, there is limited literature present on this topic which compares both endoscopic and microscopic tympanoplasty. So to fill this lacunae the present study has been undertaken.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 210

Inclusion Criteria

All patients willing to participate in the study.

Exclusion Criteria

All patients above the age of 60 years.
Patients suffering from diabetes , hypertension, tuberculosis , any immunocompromised disease .

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft success rate	At 3 months

Secondary Outcome Measures

Name	Time	Method
Hearing level

Trial Locations

Locations (1): Rohilkhand medical college
🇮🇳
Bareilly, UTTAR PRADESH, India
Rohilkhand medical college
🇮🇳Bareilly, UTTAR PRADESH, India
Dr Abhinav Srivastava
Principal investigator
9794956306
drabhinavsrivastava7@gmail.com