Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05554796 |
| Other study ID # |
MS.21.11.1758 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
October 1, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
