Otosclerosis of Middle EarNCT05554796
Endoscopic Classic Versus Reversal Stapedotomy
A study testing Endoscopic classic stapedotomy and Endoscopic reversal stapedotomy in people with Otosclerosis of Middle Ear, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy. Patients and Methods Study design: This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otosclerosis of Middle Ear
- What is being tested?
- Endoscopic classic stapedotomy and Endoscopic reversal stapedotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Oct 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
- Patients with history of gradual progressive hearing loss with normal otoscopy.
- No history of ear discharge.
- No history of ipsilateral ear surgery.
- Air bone gap >20 dB with lost stapedial reflex
Who cannot join
- Cases who did not meet the inclusion criteria.
- Revision cases.
- Cases that lost to follow up.
- All cases with narrow oval window niche or obliterated footplate, because those are the contraindications of reversal technique as described by Fisch (Fisch et al., 1994).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Endoscopic Stapedotomy: Classic Versus Reversal Technique
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy.
Patients and Methods
Read more
Study design:
This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy.
The two groups will compared to each other as regard, A. Intra-operative time (in minutes) B. Hearing outcome. C. Surgical complications
Read the detailed description
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy.
Patients and Methods
Study design:
This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy.
Inclusion criteria:
Patients with history of gradual progressive hearing loss with normal otoscopy. No history of ear discharge. No history of ipsilateral ear surgery. Air bone gap >20 dB with lost stapedial reflex
Exclusion criteria:
Cases who did not meet the inclusion criteria. Revision cases. Cases that lost to follow up. All cases with narrow oval window niche or obliterated footplate, because those are the contraindications of reversal technique as described by Fisch (Fisch et al., 1994).
The two groups will compared to each other as regard,
- Intra-operative time (in minutes):
Starting from the incision till repositioning of the flap. B. Hearing outcome. Hearing outcomes will include the average air conduction pure-tone threshold (in dB HL) and a word recognition score (WRS, in %). The data will be reported on a scattergram relating average air conduction pure-tone threshold to the WRS.
Preoperative and postoperative air conduction (AC) and bone conduction (BC) thresholds will be recorded at frequencies of 0.5, 1, 2, and 3 khz. The air-bone gap (ABG) will be recorded as the difference between AC and BC thresholds. Postoperative air bone gap will be graded as grade A (0-10 dB), grade B (11-20 dB), grade C (21-30 dB) and grade D (>30 dB).
- Surgical complications:
Vertigo. Incus subluxation. Corda tympani nerve injury. Tympanic membrane tear. Perilymph gusher. Floating footplate. Postoperative pain. Perilymph fistula. Immediate or late sensory neural hearing loss.
Method:
All cases planned to be included in this study will be subjected to:
History taking:
Personal history, past history of medical diseases, past history of surgery and family history.
Examination: routine ENT examination to exclude any other ear disease.
Investigations:
- PTA ,Tympanogram. B. Lab investigations: Pre-operative full lab(CBC, INR, LFT,virology)
Surgeries:
Patients will be operated under local anesthesia, and the transcanal approach will be the standard approach in both groups. Zero and thirty degree, 4 mm diameter, 18 cm length endoscopes and camera will be used.
Group 1:
Patients in this group will undergo classic stapedotomy where removal of stapes superstructure will be performed in the beginning followed by perforation of footplate and finally insertion of the Teflon piston.
Group 2:
Patients in this group will undergo reversal stapedotomy where perforation of footplate and insertion of Teflon piston will be done at the beginning followed by removal of stapes superstructure.
Statistical analysis:- Data analysis will be carried out using statistical software program (SPSS for Windows, version 28, USA). Variables will be presented as mean ± standard deviations (SDs), and percentages. The preoperative and postoperative hearing results (AC and BC and ABG) will be compared utilizing the paired t-test. Statistical significance will be considered at P <0.05.
- Conditions
- Otosclerosis of Middle Ear
- Being tested
- Endoscopic classic stapedotomy, Endoscopic reversal stapedotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic classic stapedotomyProcedure or surgery
Patients in this group will undergo classic stapedotomy starting with removal of stapes superstructure then perforation of footplate and finally insertion of the Teflon piston.
Endoscopic reversal stapedotomyProcedure or surgery
Patients in this group will undergo reversal stapedotomy where perforation of footplate and insertion of Teflon piston will be done at the beginning followed by removal of stapes superstructure.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic classic stapedotomy | Experimental | This groups contains 30 patients and will undergo classic stapedotomy Receives: Procedure: Endoscopic classic stapedotomy |
| Endoscopic reversal stapedotomy | Experimental | This groups contains 30 patients and will undergo reversal stapedotomy Receives: Procedure: Endoscopic reversal stapedotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average air conduction pure-tone threshold
The average air conduction pure-tone threshold (in dB HL) will be calculated from pure-tone audiometry and presented in decibels (dB)
Measured: 3 months
Word recognition score
The word recognition score will be calculated from the the speech audiometry and presented as percentage (%)
Measured: 3 months
Average air bone gap
Preoperative and postoperative air conduction (AC) and bone conduction (BC) thresholds will be recorded at frequencies of 0.5, 1, 2, and 3 khz. The air-bone gap (ABG) will be recorded as the difference between AC and BC thresholds. Postoperative air bone gap will be graded as grade A (0-10 dB), grade B (11-20 dB), grade C (21-30 dB) and grade D (>30 dB).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otosclerosis of 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hemdan, Mansoura University
- Investigators
- Ahmed Hemdan, MD, Principal investigator, Lecturer of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554796
- Sponsor's protocol ID
- MS.21.11.1758
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Stapedotomy: Classic Versus Reversal Technique
- ClinicalTrials.gov ID
- NCT05554796
- Acronym / sponsor ID
- MS.21.11.1758
- Conditions
- Otosclerosis of Middle Ear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 26 Sep 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.
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy.
Patients and Methods
Study design:
This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy.
The two groups will compared to each other as regard, A. Intra-operative time (in minutes) B. Hearing outcome. C. Surgical complications
Detailed description
Aim of The Work The aim of this study is to compare hearing outcome and surgical complications between classic and reversal endoscopic stapedotomy.
Patients and Methods
Study design:
This study is a randomized clinical study and will be carried out at Otorhinolaryngology department at Mansoura University Hospitals. The study will be conducted among 60 patients with otosclerosis who will undergo endoscopic stapedotomy. The patients will be divided into two groups. The first group (group 1) 30 patients will undergo endoscopic classic stapedotomy while the second group (group 2) 30 patients will undergo endoscopic reversal stapedotomy.
Inclusion criteria:
Patients with history of gradual progressive hearing loss with normal otoscopy. No history of ear discharge. No history of ipsilateral ear surgery. Air bone gap >20 dB with lost stapedial reflex
Exclusion criteria:
Cases who did not meet the inclusion criteria. Revision cases. Cases that lost to follow up. All cases with narrow oval window niche or obliterated footplate, because those are the contraindications of reversal technique as described by Fisch (Fisch et al., 1994).
The two groups will compared to each other as regard,
- Intra-operative time (in minutes):
Starting from the incision till repositioning of the flap. B. Hearing outcome. Hearing outcomes will include the average air conduction pure-tone threshold (in dB HL) and a word recognition score (WRS, in %). The data will be reported on a scattergram relating average air conduction pure-tone threshold to the WRS.
Preoperative and postoperative air conduction (AC) and bone conduction (BC) thresholds will be recorded at frequencies of 0.5, 1, 2, and 3 khz. The air-bone gap (ABG) will be recorded as the difference between AC and BC thresholds. Postoperative air bone gap will be graded as grade A (0-10 dB), grade B (11-20 dB), grade C (21-30 dB) and grade D (>30 dB).
- Surgical complications:
Vertigo. Incus subluxation. Corda tympani nerve injury. Tympanic membrane tear. Perilymph gusher. Floating footplate. Postoperative pain. Perilymph fistula. Immediate or late sensory neural hearing loss.
Method:
All cases planned to be included in this study will be subjected to:
History taking:
Personal history, past history of medical diseases, past history of surgery and family history.
Examination: routine ENT examination to exclude any other ear disease.
Investigations:
- PTA ,Tympanogram. B. Lab investigations: Pre-operative full lab(CBC, INR, LFT,virology)
Surgeries:
Patients will be operated under local anesthesia, and the transcanal approach will be the standard approach in both groups. Zero and thirty degree, 4 mm diameter, 18 cm length endoscopes and camera will be used.
Group 1:
Patients in this group will undergo classic stapedotomy where removal of stapes superstructure will be performed in the beginning followed by perforation of footplate and finally insertion of the Teflon piston.
Group 2:
Patients in this group will undergo reversal stapedotomy where perforation of footplate and insertion of Teflon piston will be done at the beginning followed by removal of stapes superstructure.
Statistical analysis:- Data analysis will be carried out using statistical software program (SPSS for Windows, version 28, USA). Variables will be presented as mean ± standard deviations (SDs), and percentages. The preoperative and postoperative hearing results (AC and BC and ABG) will be compared utilizing the paired t-test. Statistical significance will be considered at P <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic classic stapedotomy | Experimental | Procedure: Endoscopic classic stapedotomyThis groups contains 30 patients and will undergo classic stapedotomy |
| Endoscopic reversal stapedotomy | Experimental | Procedure: Endoscopic reversal stapedotomyThis groups contains 30 patients and will undergo reversal stapedotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with history of gradual progressive hearing loss with normal otoscopy.
- No history of ear discharge.
- No history of ipsilateral ear surgery.
- Air bone gap >20 dB with lost stapedial reflex
Key exclusion criteria (4 listed)
- Cases who did not meet the inclusion criteria.
- Revision cases.
- Cases that lost to follow up.
- All cases with narrow oval window niche or obliterated footplate, because those are the contraindications of reversal technique as described by Fisch (Fisch et al., 1994).
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 classic stapedotomyPatients in this group will undergo classic stapedotomy starting with removal of stapes superstructure then perforation of footplate and finally insertion of the Teflon piston. | Procedure or surgery | Endoscopic classic stapedotomy |
| Endoscopic reversal stapedotomyPatients in this group will undergo reversal stapedotomy where perforation of footplate and insertion of Teflon piston will be done at the beginning followed by removal of stapes superstructure. | Procedure or surgery | Endoscopic reversal stapedotomy |
Primary outcome
Average air conduction pure-tone threshold
Time frame: 3 months
The average air conduction pure-tone threshold (in dB HL) will be calculated from pure-tone audiometry and presented in decibels (dB)
Word recognition score
Time frame: 3 months
The word recognition score will be calculated from the the speech audiometry and presented as percentage (%)
Average air bone gap
Time frame: 3 months
Preoperative and postoperative air conduction (AC) and bone conduction (BC) thresholds will be recorded at frequencies of 0.5, 1, 2, and 3 khz. The air-bone gap (ABG) will be recorded as the difference between AC and BC thresholds. Postoperative air bone gap will be graded as grade A (0-10 dB), grade B (11-20 dB), grade C (21-30 dB) and grade D (>30 dB).
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 31 Oct 2022.
Related trials for Otosclerosis of Middle Ear
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
Ahmed Hemdan, MD principal investigator
Lecturer of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic classic stapedotomy and Endoscopic reversal stapedotomy in people with Otosclerosis of Middle Ear, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 4 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 31 Oct 2022. 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 Egypt. 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?
Average air conduction pure-tone threshold (time frame: 3 months). The study lists 3 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 31 Oct 2022.