Endoscopic Classic Versus Reversal Stapedotomy
Primary Purpose
Otosclerosis of Middle Ear
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic classic stapedotomy
Endoscopic reversal stapedotomy
Sponsored by
About this trial
This is an interventional treatment trial for Otosclerosis of Middle Ear
Eligibility Criteria
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).
Sites / Locations
- Mansoura University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Endoscopic classic stapedotomy
Endoscopic reversal stapedotomy
Arm Description
This groups contains 30 patients and will undergo classic stapedotomy
This groups contains 30 patients and will undergo reversal stapedotomy
Outcomes
Primary Outcome Measures
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)
Word recognition score
The word recognition score will be calculated from the the speech audiometry and presented as percentage (%)
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05554796
First Posted
September 21, 2022
Last Updated
October 28, 2022
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT05554796
Brief Title
Endoscopic Classic Versus Reversal Stapedotomy
Official Title
Endoscopic Stapedotomy: Classic Versus Reversal Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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,
A. 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).
C. 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:
A. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otosclerosis of Middle Ear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic classic stapedotomy
Arm Type
Experimental
Arm Description
This groups contains 30 patients and will undergo classic stapedotomy
Arm Title
Endoscopic reversal stapedotomy
Arm Type
Experimental
Arm Description
This groups contains 30 patients and will undergo reversal stapedotomy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic classic stapedotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic reversal stapedotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average air conduction pure-tone threshold
Description
The average air conduction pure-tone threshold (in dB HL) will be calculated from pure-tone audiometry and presented in decibels (dB)
Time Frame
3 months
Title
Word recognition score
Description
The word recognition score will be calculated from the the speech audiometry and presented as percentage (%)
Time Frame
3 months
Title
Average air bone gap
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hemdan, MD
Organizational Affiliation
Lecturer of Otorhinolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia Governorate
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
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Endoscopic Classic Versus Reversal Stapedotomy
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