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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coblation-assisted dilatation group | Active Comparator |
| |
| Modified Maddern procedure group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Airway diameter | assessment of the diameter of the airway after the procedure by endoscopic examination | 3, 6, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| subjective evaluation of breathing | 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. |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Mansoura University | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 35261874 | 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. | |
| 35634800 |
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| 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. |
|
| 3, 6, and 12 months |
| 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. |
| 37194674 | 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. |