Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical EffectNCT05182268
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
An observational study of Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
- What is being tested?
- endoscopic ear surgery and microscopic ear surgery
- Type of treatment
- Surgery or procedure
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 30 Mar 2021
- Phase
- Observational
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Patients who postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement. The extent of disease was confirmed by preoperative HRCT temporal bone. 2. The patients undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery. 3. have completely clinical characteristics, follow-up data and/or postoperative audiometric data
Who may be able to join
- postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement
- the extent of disease was confirmed by preoperative HRCT temporal bone
- undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery
Who cannot join
- were lacking in clinical characteristics
- had not preoperative audiometric data
- missed the follow-up data
- were lacking in surgical times
- were microscopic combined endoscopic ear surgery
About this study
Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.
Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.
- Being tested
- endoscopic ear surgery, microscopic ear surgery
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ear surgeryProcedure or surgery
a ear surgery via endoscopic
microscopic ear surgeryProcedure or surgery
a ear surgery via microscopic
| Study group | Role | What they receive |
|---|---|---|
| endoscopic ear surgery group(EES) | Not described Receives: Procedure: endoscopic ear surgery | |
| microscopic ear surgery group(MES) | Not described Receives: Procedure: microscopic ear surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure Tone Average(PTA)
estimate the auditory acuity
Measured: at least 1 year
Air-Bone Gap(A-B Gap)
estimate the auditory acuity
Measured: at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Nov 2016
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical EffectStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182268
- Sponsor's protocol ID
- SunYatsenU2H_YangH01
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05182268
- Acronym / sponsor ID
- SunYatsenU2H_YangH01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 10 Jan 2022 (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.
Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.
Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic ear surgery group(EES) | – | Procedure: endoscopic ear surgery |
| microscopic ear surgery group(MES) | – | Procedure: microscopic ear surgery |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Patients who postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement. The extent of disease was confirmed by preoperative HRCT temporal bone. 2. The patients undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery. 3. have completely clinical characteristics, follow-up data and/or postoperative audiometric data
Key inclusion criteria (3 listed)
- postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement
- the extent of disease was confirmed by preoperative HRCT temporal bone
- undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery
Key exclusion criteria (5 listed)
- were lacking in clinical characteristics
- had not preoperative audiometric data
- missed the follow-up data
- were lacking in surgical times
- were microscopic combined endoscopic ear surgery
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 |
|---|---|---|
| endoscopic ear surgerya ear surgery via endoscopic | Procedure or surgery | endoscopic ear surgery group(EES) |
| microscopic ear surgerya ear surgery via microscopic | Procedure or surgery | microscopic ear surgery group(MES) |
Primary outcome
Pure Tone Average(PTA)
Time frame: at least 1 year
estimate the auditory acuity
Air-Bone Gap(A-B Gap)
Time frame: at least 1 year
estimate the auditory acuity
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 10 Jan 2022.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 5 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Pure Tone Average(PTA) (time frame: at least 1 year). The study lists 2 primary outcomes in all. 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 10 Jan 2022.