Clinical trial NCT05554796: Endoscopic Classic Versus Reversal Stapedotomy
Official title: Endoscopic Stapedotomy: Classic Versus Reversal Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otosclerosis of Middle Ear
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Average air conduction pure-tone threshold
timeFrame: 3 months
measure: Word recognition score
timeFrame: 3 months
measure: Average air bone gap
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: Dakahlia Governorate
Study officials:
affiliation: Lecturer of Otorhinolaryngology
name: Ahmed Hemdan, MD
role: PRINCIPAL_INVESTIGATOR
References: