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

NCT07303673 | Completed

• 1 other identifier: MD.24.05.858
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Subglottic Stenosis (SGS)

Outcome Measures

Primary Outcomes (1)

• Airway diameter

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

  3, 6, and 12 weeks

Secondary Outcomes (1)

• subjective evaluation of breathing

  3, 6, and 12 months

Study Arms (2)

Coblation-assisted dilatation group

ACTIVE COMPARATOR

Procedure: Coblation-assisted dilatation

Modified Maddern procedure group

ACTIVE COMPARATOR

Procedure: Modified Maddern procedure

Interventions

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.

Coblation-assisted dilatation group

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.

Modified Maddern procedure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (4)

• Kavookjian, H., & Hillel, A. (2023). Endoscopic laryngotracheoplasty (Maddern procedure) for idiopathic subglottic stenosis. Operative Techniques in Otolaryngology-Head and Neck Surgery, 34(2), 115-119.

  RESULT

• Pasick LJ, Anis MM, Rosow DE. An Updated Review of Subglottic Stenosis: Etiology, Evaluation, and Management. Curr Pulmonol Rep. 2022;11(2):29-38. doi: 10.1007/s13665-022-00286-6. Epub 2022 Mar 3.

  PMID: 35261874 RESULT

• Wijermars LGM, Hoekstra CEL, Nguyen TTT, Stevens MF, Dikkers FG. New Treatment Strategy for Subglottic Stenosis Using the Trachealator, a Novel Non-occlusive Balloon. Laryngoscope. 2022 Nov;132(11):2202-2205. doi: 10.1002/lary.30234. Epub 2022 May 30. No abstract available.

  PMID: 35634800 RESULT

• Lorenz RR. The Evolution and Outcomes of the "Maddern Procedure" for the Treatment of Subglottic Stenosis. Laryngoscope. 2023 Nov;133(11):3100-3108. doi: 10.1002/lary.30752. Epub 2023 May 17.

  PMID: 37194674 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 26, 2025
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)