A study analyze the effect of addition of endoscope to microscopic tympanomastoid exploration in case of Chronic Otitis Media (Squamous) disease and evaluate its outcome

Not yet recruiting

Conditions: Unspecified cholesteatoma,

Registration Number: CTRI/2023/08/056627

Lead Sponsor: Armed Forces Medical College

Brief Summary: Background-

The surgical procedure for Chronic Otitis Media Squamous (Active) can either be a canal wall up (CWU) or a canal wall down (CWD) procedure. Both procedures have their advantages and disadvantages. Disease eradication being the primary aim of the surgery, its important to achieve complete clearance of the disease from the middle ear and mastoid. The hidden/ difficult to reach areas include the sinus tympani, deep tip cells, sinodural angle cells and deep supratubal recess. Literature states, intraoperative residual cholesteatoma rates of 13% in CWU mastoidectomy operation and 11.8% in CWD mastoidectomy operation when using microscope.

In contemporary practice, most otologists favour CWU surgery as far as possible in order to preserve normal anatomy alongwith disease clearance. With the advent of modern technology with better illumination, better optics and better magnification this has been possible to a large extent.

Traditionally the otomicroscope has been used for these procedures, however with the advent of endoscopes it has been demonstrated that previously hidden/ difficult areas have become more accessible and itâ€™s the way ahead for these surgeries. The endoscope has been used for grommet insertion, tympanoplasty and few cases of mastoid surgeries. The proponents of endoscope state its advantage of better visualization and better maneuverability in comparison to otomicroscope. However, the exact role of an endoscope in mastoidectomy has not been established.

This study aims to study the effect of addition of endoscope to traditional microscopic surgery in our subset of patients.

Purpose-

Primary Objective - To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy

Secondary Objective- To Evaluate the functional outcomes of in terms of disease progression and audiological outcomes

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

All consenting patients with Chronic Otitis Media Squamous (active) with involvement of more than 1 site as per STAM CO classification.

Exclusion Criteria

Patients with Chronic Otitis Media Squamous (Inactive) b.
Patients with complications of Chronic Otitis Media Squamous c.
Patients with posterior canal wall erosion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate effect of addition of endoscope to microscopic surgery in terms of visualization of difficult areas, disease clearance from difficult areas and preservation of normal anatomy	Intraoperative

Secondary Outcome Measures

Name	Time	Method
To evaluate functional outcomes in terms of disease progression and audiological results	3 months

Trial Locations

Locations (1): COMMAND HOSPITAL SOUTHERN COMMAND, PUNE
🇮🇳
Pune, MAHARASHTRA, India
COMMAND HOSPITAL SOUTHERN COMMAND, PUNE
🇮🇳Pune, MAHARASHTRA, India
Abhishek Patel
Principal investigator
07435888753
patel.abhishek13@gmail.com