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COMPLETED
NCT07896200
NA

Comparison of Outcomes of Microscopic Mastoidectomy With and Without Check Endoscopy

Sponsor: Sheikh Zayed Federal Postgraduate Medical Institute

View on ClinicalTrials.gov

Summary

Cholesteatoma is a serious otological condition and a major challenge for otolaryngologists worldwide. If left undetected and untreated, it can erode the surrounding bone, ear ossicles, facial nerve canal, bony labyrinth or intracranial cavity, resulting in varying grades of hearing loss, facial paralysis, vertigo or intracranial complications. The main management is complete surgical excision, traditionally performed under the microscope. The main problem in management is recidivism, either as residual disease or as recurrence. These limitations can be reduced with the complementary use of the endoscope, which allows visualization of hidden areas of the middle ear. In recent years, the otoendoscope, used either exclusively or as an adjunct to the microscope, has gained popularity in cholesteatoma surgery. The main benefit of this combination is identification of residual cholesteatoma and prevention of recurrence. This randomized controlled trial was conducted in the Department of ENT, Shaikh Zayed Hospital, Lahore. Eligible participants were allocated by lottery method to two groups. Group A underwent microscopic mastoidectomy (canal wall up or canal wall down) without check endoscopy. Group B underwent microscopic mastoidectomy followed by check endoscopy in the same surgical session. All participants were operated on under general anesthesia by the same senior consultant otolaryngologist, with the researcher as assistant. Participants were followed up in the outpatient department at 1, 3 and 6 months. Both groups were compared for residual cholesteatoma and recurrence of cholesteatoma. The study measures the role of check endoscopy as an adjunct to microscopic cholesteatoma surgery in terms of identifying residual cholesteatoma and the rate of subsequent recurrence. The findings add to local scientific data on cholesteatoma management and may help improve the combined microscopic and endoscopic approach to mastoidectomy for cholesteatoma excision.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-01-01

Completion Date

2022-12-30

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

PROCEDURE

Microscopic Mastoidectomy

Excision of cholesteatoma by microscopic mastoidectomy (canal wall up or canal wall down) under general anesthesia.

PROCEDURE

Check Endoscopy

Endoscopic inspection of the sinus tympani, anterior epitympanum, protympanum and retrotympanum after microscopic excision, with removal of any residual cholesteatoma in the same session. Arm Groups: Group B only

Locations (1)

Shaikh Zayed Hospital

Lahore, Punjab Province, Pakistan