Outcome of Resection Anastomosis and Long Term Stenting With Montgomery Tube Operations in Management of Grade 3 Benign Laryngotracheal Stenosis

Laryngotracheal stenosis is a challenging problem in the field of laryngology. In the majority of patients, acquired stenosis of the larynx and trachea is due to accidental trauma, prolonged intubations, or tracheostomy. Congenital stenosis, caustic injury, and granulomatous diseases are also etiological factors in laryngotracheal stenosis (Grenier PA et al, 2009).

Tracheal stenosis can occur following tracheostomy or endotracheal intubation with inappropriate cuff pressure. It is due to pressure necrosis at the site of the cuff. Initially, there is inflammation of the damaged mucosa with increased secretion and secondary infection. Prolonged ischemia and secondary infection cause necrosis of the tracheal wall and exposure and sequestration of the cartilaginous rings. This damage results in the formation of granulation tissue and collapse of the tracheal wall (Satish Nair et al, 2014).

The tracheal stenosis is classified as simple, which is a soft, short segment web-like narrowing often limited to the mucosa only or complex stenosis, which is a hard, long-segment stricture with destruction of tracheal cartilages and fibrosis. Post tracheostomy stenosis occurs most commonly at the stoma site or less commonly at the site where the tip of the tube has impinged on the tracheal mucosa (Liu J et al, 2015).

The symptoms are generally insidious. Most arise 1 to 6 weeks after extubation, and early symptoms are often not recognized. The most common symptoms include shortness of breath, cough, recurrent pneumonia, wheezing, stridor, and cyanosis over time. Dyspnea is often the symptom until the tracheal diameter is 50% smaller than normal. When the tracheal diameter is 25% of its normal size, dyspnea and stridor may occur even at rest. These symptoms can be confused with other respiratory diseases (Rubikas R et al, 2014).

Study Overview

• Status: Recruiting
• Conditions: Grade 3 Benign Laryngotracheal Stenosis
• Intervention / Treatment: Procedure: resection anastomosis

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: awatef m ahmed, assisstant lecturer; Phone Number: 01001126391; Email: awatef.ahmed@med.edu.eg
• Study Contact Backup: Name: Ibrahim r mohamed; Phone Number: 01005766816

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University hospitals
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- patients who are diagnosed with layngotracheal stenosis either post tracheostomy or post intubation

Exclusion Criteria:

• The exclusion criteria will be patients who underwent laryngeal split and cartilaginous grafting; patients who underwent carinal resection; patients with incomplete records; and resection due to conditions other than post intubation tracheal stenosis (e.g., airway tumors, idiopathic stenosis, trauma, Wegener' granulomatosis and chronic relapsing polychondritis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: resection anastomosis; resection of the stenotic part of the trachea and then doing re anastomosis	Procedure: resection anastomosis; resection of stenotic part of trachea and reanastmosis; Other Names: long term stenting with Montgomery tube
Active Comparator: long term stenting with Montgomery tube; application of T shaped Montgomery tube for 6 months	Procedure: resection anastomosis; resection of stenotic part of trachea and reanastmosis; Other Names: long term stenting with Montgomery tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful	release of respiratory distress	12 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
• Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7. doi: 10.1097/00005537-200108000-00001.
• Weksler B. Commentary: The role of gastroesophageal reflux in patients with acquired tracheal stenosis. J Thorac Cardiovasc Surg. 2019 Dec;158(6):1708-1709. doi: 10.1016/j.jtcvs.2019.08.071. Epub 2019 Sep 19. No abstract available.
• Liu J, Zhang CP, Li Y, Dong S. Post-intubation tracheal stenosis after management of complicated aortic dissection: a case series. J Cardiothorac Surg. 2015 Nov 4;10:148. doi: 10.1186/s13019-015-0357-z.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: soh-Med-24-06-01MD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No