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Clinical Trials/NCT07303673
NCT07303673
Completed
Not Applicable

Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis: a Randomized Clinical Trial

Mansoura University1 site in 1 country30 target enrollmentStarted: June 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Airway diameter

Overview

Brief Summary

This study compares the effectiveness of Coblation-assisted endoscopic airway dilatation with the modified Maddern procedure-which involves endoscopic excision of scar tissue followed by buccal mucosal grafting-in patients with subglottic and/or upper tracheal stenosis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All consecutive patients with (grade II, III) subglottic and/or upper tracheal stenosis according to Myer-Cotton grading system
  • all age groups (children and adults)

Exclusion Criteria

  • Patients with cervical spine diseases where an extended position during the procedure could be problematic.
  • Previous neck or oral cavity irradiation.
  • chronic uncontrolled debilitating diseases that might interfere with the healing process e.g. (diabetes mellitus, renal failure, decompensated liver diseases).

Outcomes

Primary Outcomes

Airway diameter

Time Frame: 3, 6, and 12 weeks

assessment of the diameter of the airway after the procedure by endoscopic examination

Secondary Outcomes

  • subjective evaluation of breathing(3, 6, and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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