Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis

Not Applicable

Not yet recruiting

• Conditions: Tracheal Stenosis; Subglottic Stenosis

• Registration Number: NCT06917222
• Lead Sponsor: Mansoura University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-09
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success Rate of Procedure	3-6 months	Defined as the absence of stridor or the need for re-intervention within a defined follow-up period (3 months

Secondary Outcome Measures

Name	Time	Method
Time to Decannulation	3 months	Time taken for patients to be successfully decannulated, which can be indicative of recovery and airway stability.
Complication Rates	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
Duration of Hospital Stay	3 months	Measured from the day of surgery to discharge