Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery

February 17, 2024 updated by: Rehab Abdelal Mohamed, Assiut University
Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Regarding discharge Time of epithelizqtion Hearing outcomes Quality of life

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital
      • Assiut, Egypt
        • Rehab Abd Elal Mohammed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • all patients who have extensive or recuutrent cholesteatoma undergoing canal wall down tympanomastoidectomy

Exclusion Criteria:

  • not willing for surgery

  • Malignancy

    • Patients with intracranial complication
  • Residual cholesteatoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Muscle obliteration
Mastoid cavity obliteration by muscle
Procedure: Canal wall down tympanomastoidectomy
Mastoid cavity obliteration by in canal wall down tympanomastoidectomy tympanomastoidectomy in cholesteatoma surgery
Active Comparator: Bone obliteration
Mastoid cavity obliteration by bone
Procedure: Canal wall down tympanomastoidectomy
Mastoid cavity obliteration by in canal wall down tympanomastoidectomy tympanomastoidectomy in cholesteatoma surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of mastoid cavity in mm
Time Frame: 1 month
Endoscopic examination of the mastoid cavity after 1month to evaluate the degree of epithelization and if there is discharge .
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mastoid obliteration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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