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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07303673

Enrollment

Registered

2025-12-26

Start date

2024-06-01

Completion date

2025-12-01

Last updated

2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subglottic Stenosis (SGS)

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.

Interventions

PROCEDURECoblation-assisted dilatation

endoscopic Coblation-assisted dilatation is done for subglottic and / or upper tracheal stenosis. Radial incisions are done using the coblation technique, followed by balloon dilatation.

PROCEDUREModified Maddern procedure

endoscopic excision of the scar tissue is done in patients with subglottic and / or upper tracheal stenosis. The resultant raw surface is covered with a buccal mucosal graft harvested from the patient cheek mucosa. The donor site is closed by primary suturing.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
Airway diameter	3, 6, and 12 weeks	assessment of the diameter of the airway after the procedure by endoscopic examination

Secondary

Measure	Time frame	Description
subjective evaluation of breathing	3, 6, and 12 months	the breathing is evaluated subjectively using the dyspnea handicap index. The Dyspnea Handicap Index (DHI) is a validated self-reported questionnaire consisting of 10 items, each scored as 0 (never), 2 (sometimes), or 4 (always), yielding a total score from 0 to 40, with higher scores indicating greater severity of dyspnea-related functional and emotional handicap.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026