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

NCT ID: NCT07303673

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Subglottic Stenosis (SGS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coblation-assisted dilatation group

Group Type ACTIVE_COMPARATOR

Coblation-assisted dilatation

Intervention Type 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 group

Group Type ACTIVE_COMPARATOR

Modified Maddern procedure

Intervention Type 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.

Interventions

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Coblation-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.

Intervention Type PROCEDURE

Modified 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type 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.

Reference Type RESULT
PMID: 35261874 (View on PubMed)

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.

Reference Type RESULT
PMID: 35634800 (View on PubMed)

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.

Reference Type RESULT
PMID: 37194674 (View on PubMed)

Other Identifiers

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MD.24.05.858

Identifier Type: -

Identifier Source: org_study_id