NCT06268938

Brief Summary

Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Sep 2023Dec 2028

Study Start

First participant enrolled

September 4, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5.2 years

First QC Date

November 27, 2023

Last Update Submit

February 17, 2024

Conditions

Cholesteatoma

Outcome Measures

Primary Outcomes (1)

  • Size of mastoid cavity in mm

    Endoscopic examination of the mastoid cavity after 1month to evaluate the degree of epithelization and if there is discharge .

    1 month

Study Arms (2)

Muscle obliteration

EXPERIMENTAL

Mastoid cavity obliteration by muscle

Procedure: Canal wall down tympanomastoidectomy

Bone obliteration

ACTIVE COMPARATOR

Mastoid cavity obliteration by bone

Procedure: Canal wall down tympanomastoidectomy

Interventions

Canal wall down tympanomastoidectomyPROCEDURE

Mastoid cavity obliteration by in canal wall down tympanomastoidectomy tympanomastoidectomy in cholesteatoma surgery

Bone obliterationMuscle obliteration

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • not willing for surgery
  • Malignancy
  • Patients with intracranial complication
  • Residual cholesteatoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut university hospital

Asyut, Egypt

Location

Rehab Abd Elal Mohammed

Asyut, Egypt

Location

Related Publications (5)

  • Mehta RP, Harris JP. Mastoid obliteration. Otolaryngol Clin North Am. 2006 Dec;39(6):1129-42. doi: 10.1016/j.otc.2006.08.007.

    PMID: 17097437BACKGROUND

  • Khalil HS, Windle-Taylor PC. Canal wall down mastoidectomy: A long term commitment to the outpatients? BMC Ear Nose Throat Disord. 2003 Sep 4;3(1):1. doi: 10.1186/1472-6815-3-1.

    PMID: 12956889BACKGROUND

  • Illes K, Meznerics FA, Dembrovszky F, Fehervari P, Banvolgyi A, Csupor D, Hegyi P, Horvath T. Mastoid Obliteration Decreases the Recurrent and Residual Disease: Systematic Review and Meta-analysis. Laryngoscope. 2023 Jun;133(6):1297-1305. doi: 10.1002/lary.30413. Epub 2022 Sep 28.

    PMID: 36169349BACKGROUND

  • Krol B, Cywka KB, Skarzynska MB, Skarzynski PH. Mastoid obliteration with S53P4 bioactive glass after canal wall down mastoidectomy: Preliminary results. Am J Otolaryngol. 2021 Mar-Apr;42(2):102895. doi: 10.1016/j.amjoto.2020.102895. Epub 2021 Jan 5.

    PMID: 33429176BACKGROUND

  • Weiss NM, Bachinger D, Botzen J, Grossmann W, Mlynski R. Mastoid cavity obliteration leads to a clinically significant improvement in health-related quality of life. Eur Arch Otorhinolaryngol. 2020 Jun;277(6):1637-1643. doi: 10.1007/s00405-020-05881-4. Epub 2020 Mar 6.

    PMID: 32144569BACKGROUND

MeSH Terms

Conditions

Cholesteatoma

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

February 20, 2024

Study Start

September 4, 2023

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

EG(2)