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Endoscopic Classic Versus Reversal Stapedotomy

NCT05554796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-31

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed Hemdan, MD · Lecturer of Otorhinolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-09-01
Completion
2022-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05554796 on ClinicalTrials.gov