Cholesteatoma, Middle EarNCT07896200
Comparison of Outcomes of Microscopic Mastoidectomy With and Without Check Endoscopy
A study testing Microscopic Mastoidectomy and Check Endoscopy in people with Cholesteatoma, Middle Ear and Cholesteatoma, Residual, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholesteatoma, Middle Ear, Cholesteatoma, Residual
- What is being tested?
- Microscopic Mastoidectomy and Check Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acquired cholesteatoma diagnosed on otomicroscopy
- Any age
- Either gender
Who cannot join
- Medical conditions precluding general anesthesia
- Intracranial complication of cholesteatoma
- Previous surgery on the same ear
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Cholesteatoma, Middle Ear, Cholesteatoma, Residual
- Being tested
- Microscopic Mastoidectomy, Check Endoscopy
- Keywords
- recurrance cholesteatoma, residual choleateatoma, endoscopic mastoidectomy,, Cholesteatoma, Residual, Mastoidectomy, Check Endoscopy, Endoscopic Ear Surgery, Residual Disease
- Medical subject headings
- Cholesteatoma, Middle Ear, Cholesteatoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic MastoidectomyProcedure or surgery
Excision of cholesteatoma by microscopic mastoidectomy (canal wall up or canal wall down) under general anesthesia.
Check EndoscopyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group A: Mastoidectomy Without Check Endoscopy | Active comparator | Microscopic mastoidectomy (canal wall up or canal wall down) for cholesteatoma without check endoscopy, as per routine practice. Receives: Procedure: Microscopic Mastoidectomy |
| Group B: Mastoidectomy With Check Endoscopy | Experimental | 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. Receives: Procedure: Microscopic Mastoidectomy; Procedure: Check Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative and up to 6 months after surgery
Secondary outcomes (1)
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
Measured: 1 month, 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesteatoma, Middle EarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahira Shaukat, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896200
- Sponsor's protocol ID
- SZMC/IRB/00104/2021
- Status last verified
- Sep 2021
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after written inform consent as well maintaining anonymity data regarding residual as well recurrance of cholesteatoma will be provided if required
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Microscopic Mastoidectomy With and Without Check Endoscopy
- ClinicalTrials.gov ID
- NCT07896200
- Acronym / sponsor ID
- SZMC/IRB/00104/2021
- Conditions
- Cholesteatoma, Middle Ear, Cholesteatoma, Residual
- Keywords
- recurrance cholesteatoma, residual choleateatoma, endoscopic mastoidectomy,, Cholesteatoma, Residual, Mastoidectomy, Check Endoscopy, Endoscopic Ear Surgery, Residual Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Mastoidectomy Without Check Endoscopy | Active comparator | Procedure: Microscopic MastoidectomyMicroscopic mastoidectomy (canal wall up or canal wall down) for cholesteatoma without check endoscopy, as per routine practice. |
| Group B: Mastoidectomy With Check Endoscopy | Experimental | Procedure: Microscopic Mastoidectomy, Procedure: Check EndoscopyMicroscopic 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Acquired cholesteatoma diagnosed on otomicroscopy
- Any age
- Either gender
Key exclusion criteria (3 listed)
- Medical conditions precluding general anesthesia
- Intracranial complication of cholesteatoma
- Previous surgery on the same ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microscopic MastoidectomyExcision of cholesteatoma by microscopic mastoidectomy (canal wall up or canal wall down) under general anesthesia. | Procedure or surgery | Group A: Mastoidectomy Without Check Endoscopy, Group B: Mastoidectomy With Check Endoscopy |
| Check EndoscopyEndoscopic 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 | Procedure or surgery | Group B: Mastoidectomy With Check Endoscopy |
Primary outcome
Number of Participants with Residual Cholesteatoma
Time frame: Intraoperative and up to 6 months after surgery
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.
1 secondary outcome
Number of Participants with Recurrence of Cholesteatoma
Time frame: 1 month, 3 months and 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. after written inform consent as well maintaining anonymity data regarding residual as well recurrance of cholesteatoma will be provided if required
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microscopic Mastoidectomy and Check Endoscopy in people with Cholesteatoma, Middle Ear and Cholesteatoma, Residual, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Residual Cholesteatoma (time frame: Intraoperative and up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.