Endoscopic Classic Versus Reversal Stapedotomy

NCT05554796 | Completed

• 1 other identifier: MS.21.11.1758
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Otosclerosis of Middle Ear

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Endoscopic classic stapedotomy

EXPERIMENTAL

This groups contains 30 patients and will undergo classic stapedotomy

Procedure: Endoscopic classic stapedotomy

Endoscopic reversal stapedotomy

EXPERIMENTAL

This groups contains 30 patients and will undergo reversal stapedotomy

Procedure: Endoscopic reversal stapedotomy

Interventions

Endoscopic classic stapedotomy PROCEDURE

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 classic stapedotomy

Endoscopic reversal stapedotomy PROCEDURE

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.

Endoscopic reversal stapedotomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

• Ahmed Hemdan, MD

  Lecturer of Otorhinolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Otorhinolaryngology

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

EG (1)