An interventional study of Microscopic Mastoidectomy and Check Endoscopy in Cholesteatoma, Middle Ear and Cholesteatoma, Residual, sponsored by Sheikh Zayed Federal Postgraduate Medical Institute. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Sheikh Zayed Federal Postgraduate Medical Institute · Not applicable, Interventional, and Treatment
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.
The rationale of this study is to investigate the use of the endoscope in combination with the microscope, compared with a control group, to identify residual disease in hidden areas of the middle ear, and to assess the role of this combination in controlling recurrence of cholesteatoma. Local data are scarce, and a population gap exists in terms of sociodemographic variation. The study aims to confirm whether the combination is more successful in identifying residual cholesteatoma and preventing recurrence. The results will provide local statistics that can guide modifications to the technique to improve the outcome of cholesteatoma management.
The sample size was calculated at a 95% confidence level and 5% margin of error, with an expected cholesteatoma recurrence rate of 11% (Presutti et al., 2018).
Participants were identified through the Department of Otolaryngology outpatient clinic. Informed written consent was obtained. Demographic and clinical details (age, sex, side, duration of symptoms and history of previous surgery of the same ear) were recorded. The affected ear was examined under the microscope to confirm cholesteatoma, and high-resolution CT of the temporal bone of the same side was performed to estimate the extent of disease in the middle ear and surrounding structures.
Participants were then allocated to two groups by lottery method. Group A received microscopic mastoidectomy (canal wall up or canal wall down) without check endoscopy, which is the routine current practice for cholesteatoma surgery at the study site. Group B received microscopic mastoidectomy (canal wall up or canal wall down) with check endoscopy. All operations were performed under general anesthesia by a single senior consultant with the assistance of the researcher.
In Group B, after excision of cholesteatoma with microscopic mastoidectomy, check endoscopy was performed to visualize hidden areas of the middle ear: the sinus tympani, anterior epitympanum, protympanum and retrotympanum. The presence or absence of residual cholesteatoma was recorded according to site. Any residual cholesteatoma found by the endoscope was removed in the same session.
After surgery, participants were discharged within 24 to 72 hours and followed up in the outpatient department at 1, 3 and 6 months. At each visit, the middle ear and mastoid cavity were examined under the microscope for ear discharge or visible cholesteatoma. All information was recorded on a proforma and entered into SPSS version 23.
Quantitative variables (age, duration of symptoms) were summarized as mean and standard deviation. Qualitative variables (sex, side, presence and site of residual cholesteatoma, recurrence) were summarized as frequency and percentage. The two groups were compared for residual cholesteatoma and recurrence by cross-tabulation.
21 studies on the registry are indexed under Cholesteatoma; 5 are open to participants now.
This study's enrollment of 30 is below the median of 39 across 10 interventional studies indexed under Cholesteatoma.
Browse Cholesteatoma studies →Sheikh Zayed Federal Postgraduate Medical Institute is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Microscopic mastoidectomy (canal wall up or canal wall down) for cholesteatoma without check endoscopy, as per routine practice.
Procedure: Microscopic Mastoidectomy
Microscopic mastoidectomy (canal wall up or canal wall down) for cholesteatoma followed by check endoscopy of hidden areas of the middle ear in the same surgical session.
Procedure: Microscopic Mastoidectomy · Procedure: Check Endoscopy
Excision of cholesteatoma by microscopic mastoidectomy (canal wall up or canal wall down) under general anesthesia.
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
Number of Participants with Residual Cholesteatoma
Residual cholesteatoma identified at check endoscopy during surgery (Group B) or on microscopic examination at follow-up (both groups), recorded by site in the middle ear.
Time frame: Intraoperative and up to 6 months after surgery
Number of Participants with Recurrence of Cholesteatoma
Recurrence of cholesteatoma, defined as ear discharge or visible cholesteatoma on microscopic examination of the middle ear and mastoid cavity
Time frame: 1 month, 3 months and 6 months after surgery
Plan to share: Yes — after written inform consent as well maintaining anonymity data regarding residual as well recurrance of cholesteatoma will be provided if required
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: till 2026
Access criteria: those related to speciality will e provided the data if asked from principal investigator by email
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Jun 2022, 5 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sheikh Zayed Federal Postgraduate Medical Institute