Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis

Mansoura University

Status: Completed

Conditions: Subglottic Stenosis (SGS)

Treatments: Procedure: Modified Maddern procedure; Procedure: Coblation-assisted dilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT07303673

MD.24.05.858

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Coblation-assisted dilatation group

Active Comparator group

Treatment:

Procedure: Coblation-assisted dilatation

Modified Maddern procedure group

Active Comparator group

Treatment:

Procedure: Modified Maddern procedure