Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis

September 22, 2025 updated by: Eslam Hamed Elsayed Abdou, Mansoura University Hospital
Aim of the Work To compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

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 patients with grade III, IV acquired tracheal stenosis (e.g., due to trauma, prolonged intubation) regardless their age or sex.

    • Patient with symptomatic high grade II acquired laryngotracheal stenosis after failure of endoscopic interventions.
    • Clinical indications for surgical intervention (Symptoms of airway obstruction).
    • Feasible for surgical intervention.

Exclusion Criteria:

  • congenital tracheal stenosis

    • Malignant stenosis.
    • Severe comorbidities that contraindicate the surgery.
    • Patients refusing to sign the consent.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Slide tracheoplasty
Procedure: Slide tracheoplasty
Management of tracheal stenosis by slide tracheoplasty
Experimental: Tracheal resection anastomosis
Procedure: Tracheal resection anastomosis
Management of tracheal stenosis by tracheal resection anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Procedure
Time Frame: 3-6 months
Defined as the absence of stridor or the need for re-intervention within a defined follow-up period (3 months
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rates
Time Frame: 3 months

Evaluation of perioperative complications:

  • Immediate Complications: Airway obstruction, pneumothorax, anastomotic leak, or accidental injury to surrounding structures (e.g., RLN).
  • Delayed Complications: Stenosis, granulation tissue formation, tracheomalacia, or infection (e.g., mediastinitis).
  • Mortality Rate: Intraoperative and 30-day mortality rates
3 months
Duration of Hospital Stay
Time Frame: 3 months
Measured from the day of surgery to discharge
3 months
Time to Decannulation
Time Frame: 3 months
Time taken for patients to be successfully decannulated, which can be indicative of recovery and airway stability.
3 months

Collaborators and Investigators

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

Sponsor

Mansoura University Hospital

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)

May 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Slide tracheoplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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