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Completed

NCT Number: NCT07303673

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

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.

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Key information

Conditions

Subglottic Stenosis (SGS)

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Coblation-assisted dilatation

Procedure

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.

Modified Maddern procedure

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.

Primary outcomes

  1. Airway diameter

    Time frame: 3, 6, and 12 weeks

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

Secondary outcomes

  1. subjective evaluation of breathing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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