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Recruiting NCT06917222

Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis

No phase Interventional Tracheal Stenosis Subglottic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Slide tracheoplasty, Tracheal resection anastomosis.
Who it may be relevant to
Registry conditions: Tracheal Stenosis, Subglottic Stenosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Slide tracheoplasty
    Management of tracheal stenosis by slide tracheoplasty
  • Procedure Tracheal resection anastomosis
    Management of tracheal stenosis by tracheal resection anastomosis

Primary outcome measures

  • Success Rate of Procedure [Time frame: 3-6 months]
Secondary outcome measures (3)
  • Complication Rates [Time frame: 3 months]
  • Duration of Hospital Stay [Time frame: 3 months]
  • Time to Decannulation [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Eslam Hamed — Al Mansurah

Publications

  • Manning PB, Rutter MJ, Lisec A, Gupta R, Marino BS. One slide fits all: the versatility of slide tracheoplasty with cardiopulmonary bypass support for airway reconstruction in children. J Thorac Cardiovasc Surg. 2011 Jan;141(1):155-61. doi: 10.1016/j.jtcvs.2010.08.060. Epub 2010 Nov 5. PMID 21055774
  • Schweiger C, Cohen AP, Rutter MJ. Tracheal and bronchial stenoses and other obstructive conditions. J Thorac Dis. 2016 Nov;8(11):3369-3378. doi: 10.21037/jtd.2016.11.74. PMID 28066618
  • Smith MM, Cotton RT. Diagnosis and management of laryngotracheal stenosis. Expert Rev Respir Med. 2018 Aug;12(8):709-717. doi: 10.1080/17476348.2018.1495564. Epub 2018 Jul 12. PMID 29969925
  • Tsang V, Murday A, Gillbe C, Goldstraw P. Slide tracheoplasty for congenital funnel-shaped tracheal stenosis. Ann Thorac Surg. 1989 Nov;48(5):632-5. doi: 10.1016/0003-4975(89)90777-7. PMID 2818051
  • Zalzal HG, Behzadpour HK, Leonard J, Sinha P, Preciado DA. Systematic Review of Slide Tracheoplasty Outcomes. Ann Otol Rhinol Laryngol. 2023 May;132(5):558-565. doi: 10.1177/00034894221104955. Epub 2022 Jun 20. PMID 35723210
  • Bocage JP, Caccavale R, Lewis R, Sisler G, MacKenzie J. Tracheal stenosis. N J Med. 1990 Aug;87(8):631-4. PMID 2395535
  • de Alarcon A, Rutter MJ. Cervical slide tracheoplasty. Arch Otolaryngol Head Neck Surg. 2012 Sep;138(9):812-6. doi: 10.1001/archoto.2012.1768. PMID 22986713
  • Freitag L, Darwiche K. Endoscopic treatment of tracheal stenosis. Thorac Surg Clin. 2014 Feb;24(1):27-40. doi: 10.1016/j.thorsurg.2013.10.003. PMID 24295657

Identifiers

NCT: NCT06917222 · Slide tracheoplasty

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗