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

December 18, 2025 updated by: Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • Faculty of Medicine, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Coblation-assisted dilatation group
Procedure: 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.
Active Comparator: Modified Maddern procedure group
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MD.24.05.858

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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