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Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis

ConditionsTracheal StenosisSubglottic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMansoura University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

congenital tracheal stenosis

Malignant stenosis.

Severe comorbidities that contraindicate the surgery.

Patients refusing to sign the consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Slide tracheoplasty

    Procedure/Surgery

    Management of tracheal stenosis by slide tracheoplasty

  • Tracheal resection anastomosis

    Procedure/Surgery

    Management of tracheal stenosis by tracheal resection anastomosis

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Slide tracheoplastyExperimental treatment 1 intervention
Group B: Tracheal resection anastomosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success Rate of Procedure

Defined as the absence of stridor or the need for re-intervention within a defined follow-up period (3 months

Time frame
3-6 months

Secondary outcomes

1

Complication Rates

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

Time frame
3 months
2

Duration of Hospital Stay

Measured from the day of surgery to discharge

Time frame
3 months
3

Time to Decannulation

Time taken for patients to be successfully decannulated, which can be indicative of recovery and airway stability.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University Hospital

Lead sponsor

Source ClinicalTrials.gov
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