Endoscopic Classic Versus Reversal Stapedotomy

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

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

Study Overview

• Status: Completed
• Conditions: Otosclerosis of Middle Ear
• Intervention / Treatment: Procedure: Endoscopic classic stapedotomy; Procedure: Endoscopic reversal stapedotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Mansoura, Dakahlia Governorate, Egypt, 35511
      • Mansoura university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic classic stapedotomy; This groups contains 30 patients and will undergo classic stapedotomy	Procedure: Endoscopic classic stapedotomy; 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.
Experimental: Endoscopic reversal stapedotomy; This groups contains 30 patients and will undergo reversal stapedotomy	Procedure: Endoscopic reversal stapedotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months
Word recognition score	The word recognition score will be calculated from the the speech audiometry and presented as percentage (%)	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).	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmed Hemdan, MD, Lecturer of Otorhinolaryngology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis
• Other Study ID Numbers: MS.21.11.1758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No