Clinical trial NCT06917222: Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis
Official title: Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tracheal Stenosis
Subglottic Stenosis
Keywords: Slide tracheoplasty
Tracheal resection anastomosis
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Success Rate of Procedure
timeFrame: 3-6 months
Secondary outcomes:
measure: Complication Rates
timeFrame: 3 months
measure: Duration of Hospital Stay
timeFrame: 3 months
measure: Time to Decannulation
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Bocage JP, Caccavale R, Lewis R, Sisler G, MacKenzie J. Tracheal stenosis. N J Med. 1990 Aug;87(8):631-4.
citation: 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.
citation: 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.
citation: Grillo HC. Surgical treatment of postintubation tracheal injuries. J Thorac Cardiovasc Surg. 1979 Dec;78(6):860-75.
citation: Li C, Rutter MJ. Acquired tracheal stenosis: Cervical slide tracheoplasty. Semin Pediatr Surg. 2021 Jun;30(3):151058. doi: 10.1016/j.sempedsurg.2021.151058. Epub 2021 May 25.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.